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Nicholas M. Selby, Christopher W. McIntyre, A systematic review of the clinical effects of reducing dialysate fluid temperature, Nephrology Dialysis Transplantation, Volume 21, Issue 7, July 2006, Pages 1883–1898, https://doi.org/10.1093/ndt/gfl126
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Abstract
Background. Intradialytic hypotension (IDH) is a frequent complication of haemodialysis. Reducing the temperature of the dialysis fluid is a simple therapeutic strategy but is relatively underused. This may be due to concerns regarding its effects on symptoms and dialysis adequacy. We performed a systematic review of the literature to examine the effects of cool dialysis on intradialytic blood pressure, and to assess its safety in terms of thermal symptoms and small solute clearance.
Methods. We searched the Cochrane Central Register of Controlled Trials, Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, databases of ongoing trials, the contents of four major renal journals as well as hand-searching reference lists. We included all prospective randomized studies that compared any technique of reducing dialysate temperature with standard bicarbonate dialysis. These techniques included an empirical, fixed reduction of dialysate temperature or use of a biofeedback temperature-control device (BTM®) to deliver isothermic dialysis or programmed patient cooling.
Results. A total of 22 studies comprising 408 patients were included (16 studies examined a fixed empirical temperature reduction and six examined BTM). All studies were of crossover design and relatively short duration. IDH occurred 7.1 (95% CI, 5.3–8.9) times less frequently with cool dialysis (both fixed reduction and BTM). Post-dialysis mean arterial pressure was higher with cool-temperature dialysis by 11.3 mmHg (95% CI, 7.7–15.0). No studies reported that cool dialysis led to a reduction in dialysis adequacy as assessed by urea clearance. The frequency and severity of thermal-related symptoms were generally reported inadequately.
Conclusions. Reducing the temperature of the dialysate is an effective intervention to reduce the frequency of IDH and does not adversely affect dialysis adequacy. This applies to the fixed reduction of dialysate temperature and BTM. It remains unclear as to what extent cool-temperature dialysis causes intolerable cold symptoms during dialysis. There are no trials comparing fixed empirical temperature reduction with BTM, and no trials examining the long-term effects of cool dialysis on patient outcomes.
Introduction
Intradialytic hypotension (IDH) remains a significant cause of morbidity in the haemodialysis (HD) population, occurring in 20–30% of treatments [1]. It is also recognized that a fall in blood pressure during dialysis predicts mortality [2]. One of the simplest manoeuvres to combat IDH is to reduce the dialysate temperature, first described by Maggiore et al. in the 1980s [3]. This approach takes account of the fact that body temperature rises during standard dialysis [4]. The reasons for this are not entirely clear, but may include heat transfer to the patient from warm dialysate (especially as many dialysis patients have low baseline core temperatures), reduced heat loss from the skin due to vasoconstriction or increased thermogenesis from an inflammatory response to a blood-membrane reaction.
However, cooling the dialysate remains a relatively under-utilized technique. In part, this may be due to the fears of causing unacceptable symptoms of cold and shivering, as empirical reduction of dialysate temperature may in some patients lead to excessive cooling. In addition, there has also been concern that cooling the dialysate will lead to a reduction in dialysis adequacy due to peripheral solute sequestration as a result of greater vasoconstriction.
More recently, a biofeedback device (BTM®, Fresenius, Bad Homburg, Germany) has been developed. This device measures the temperature of blood in the arterial and venous bloodlines leaving the fistula and makes a correction for recirculation. It is able to calculate energy transfer and can make constant adjustments to the dialysate temperature during dialysis in response to the calculated body temperature. BTM can therefore be programmed in a variety of ways; it can deliver a predetermined energy balance (either negative balance or thermoneutral dialysis where energy balance is neutral), or it can deliver a prescribed change in body temperature (programmed cooling or isothermic dialysis where patient's body temperature is maintained). Isothermic dialysis requires a negative energy balance to maintain the body temperature. By reacting to an individual patient's core temperature, BTM and in particular, isothermic dialysis should theoretically avoid severe thermal symptoms. This is in contrast to the empirical reduction of dialysate temperature where individual variability in the body temperature is not taken into account.
We performed a systematic review of the literature to assess the effects of cool dialysis on IDH, blood pressure (BP) and thermal symptoms during dialysis. We also wanted to assess the effects of cool dialysis on dialysis adequacy. We sought studies that compared cool dialysis using a fixed empirical reduction of dialysis temperature with standard dialysis, or those studies in which the BTM device was used in a variety of modes.
Methods
Criteria for considering studies for this review
Types of studies
We included all prospective randomized studies that compared any technique of reducing dialysate temperature with standard dialysis. We only included studies in which bicarbonate-based dialysis was used; much of the early work on cool dialysis was done with acetate-based dialysis, which has now become obsolete as acetate transfer to the patient is recognized to strongly predispose to IDH. Since some patients can detect a reduction in dialysate temperature, we included both blinded and non-blinded studies. We included trials written in English and investigated both published and unpublished studies.
Types of participants
Male and female adult patients (age >18 years) on chronic HD for end-stage renal disease were included. Patients could be classified at baseline as either stable or unstable on dialysis. Patients treated with dialysis techniques enhanced by convection were excluded.
Types of interventions
Standard dialysis was compared with any method of reducing dialysate temperature. These methods included:
fixed, empirical reduction in dialysate temperature;
programmed patient cooling using BTM;
isothermic dialysis using BTM and
negative energy balance using BTM.
Types of outcome measures
Primary outcome measures
(1) frequency of IDH;
(2) change in blood pressure with dialysis;
(3) frequency and severity of cold sensation during dialysis;
(4) urea clearance-based dialysis adequacy (Kt/Vurea, urea reduction ratio, URR).
Secondary outcome measures
(1) changes in systemic haemodynamics during dialysis and
(2) changes in body temperature
This review was not designed to examine studies reporting thermal balance as an outcome measure.
Search strategy for identification of studies
The following search terms were used as medical subject headings and key words when searching electronic databases:
End-stage renal disease, end-stage renal failure, end-stage kidney failure, h(a)emodialysis, cool dialysis, cool temperature, isothermic, low temperature, cool dialysate, thermoneutral, blood cooling, thermal balance, energy transfer, hypotension, IDH, (in)stability, dialysis hypotension, low blood pressure, hypotensive, vascular stability, vascular reactivity.
Electronic searches
We examined the following databases:
Cochrane Central Register of Controlled Trials (CENTRAL, Issue 4),
medline 1966–2005,
embase (up to 2005) and
cumulative Index to Nursing and Allied Health Literature (CINAHL).
We also searched the contents of four major renal journals (Journal of American Society of Nephrology, American Journal of Kidney Diseases, Kidney International, and Nephrology Dialysis and Transplantation).
We searched the following databases of ongoing trials:
National Research Register (UK) (www.update-software.com)
ClinicalTrials.gov (www.clinicaltrials.gov)
Current Controlled Trials (www.controlled-trials.com)
European Clinical Trials Database (www.eudract.emea.eu.int)
All appropriate records were downloaded into a database (Endnote version 4.0, ISI ResearchSoft). Once duplicates were removed, the titles were loaded into the Review Manager Program (RevMan 4.2.8, the Cochrane Collaboration).
Hand-searches
We searched reference lists from all relevant review articles and also the reference lists from all of the studies that were obtained in full text.
Methods of the review
Trial selection
One author assessed all of the titles and abstracts identified in the search. Full-text articles were then retrieved and independently assessed by two authors for selection in the review. Differences in opinion were resolved by discussion.
Quality assessment of trials
Two reviewers independently assessed the methodological quality of the trials selected. Methodological quality was assessed by scoring allocation concealment of the studies using the Cochrane scoring system, and by scoring each paper according to the Jadad system [5]. Differences were resolved by discussion.
Particular attention was paid to the following aspects of study design:
Randomization and allocation concealment,
Adequacy of blinding (no blinding/participant/provider/outcome assessor) and
Number and handling of drop-outs.
In addition, each study was assessed for the presence of possible confounding factors that are particular to HD (stability of included patients on dialysis, ultrafiltration volumes, duration and timing of dialysis sessions, dialysis vintage and prevalence of diabetes in study population).
Data extraction
Data were extracted using a predefined form (see Appendix). When the same results were presented in more than one publication, only the publication with the most complete results was included.
Data analysis
Data were summarized statistically if of sufficient quality and if the data were presented in compatible formats. Results were divided first into possible comparisons (control dialysis vs fixed reduction in dialysate temperature, control dialysis vs biofeedback controlled reduction of dialysate temperature) and then subdivided into outcome measures.
Rates were expressed as rate ratios and compared using generic inverse variance. Continuous data were expressed as weighted mean difference (WMD). Overall results were calculated using a random-effects model.
Results
Description of studies
Trials identified
We identified a total of 112 references from a search conducted in December 2005. Of these, 64 were fully assessed and 22 were finally included in the review.
Excluded studies
A total of 42 studies were excluded after reading the entire manuscript (Table 1). The reasons for excluding trials were:
ex vivo experiments (3),
studied alternate dialysis techniques (usually haemofiltration) or additional interventions (9),
replication of data from other studies (6),
use of acetate as the principal buffer (12),
review articles (4),
assessment of thermal balance as the only outcome (5) and
abstracts for which it was not possible to obtain adequate data (3).
Study ID . | Reason for exclusion . |
---|---|
Aizawa et al. [28] | Ex vivo |
Alappan et al. [29] | Additional intervention—Ca2+ concentration in dialysate adjusted |
Bazzato et al. [30] | Same data as Bazzato et al. [31] |
Bazzato et al. [31] | Acetate dialysis |
Beerenhout et al. [32] | Ex vivo |
Coli et al. [33] | Sama data as Bazzato et al. [31] |
Daugirdas [34] | Not specific comparison of cool dialysis vs standard |
Decheva et al. [35] | Not specific comparison of cool dialysis vs standard |
Donauer et al. [36] | Compared isothermic dialysis and haemodiafiltration |
Gotch, Keen and Yarian [37] | Theoretical modelling for thermal balance |
Hegbrant et al. [38] | Same data as Hegbrant et al. [20] ASAIO J |
Karamperis, Sloth and Jensen [39] | Compared isothermic dialysis and haemodiafiltration |
Keijman et al. [40] | Thermal changes only outcome measured |
Kerr, Van and Dawborn [41] | Acetate dialysis |
Kuhlmann and Hermann[42] | Insufficient data (abstract) |
Lindholm et al. [4] | Acetate dialysis |
Maggiore et al. [3] | Acetate dialysis |
Maggiore et al. [43] | Acetate dialysis |
Maggiore et al. [44] | Review |
Maggiore et al. [45] | Same data as Maggiore et al. [3] |
Maggiore et al. [46] | Review |
Maggiore [47] | Insufficient data (abstract) |
Mahida et al. [48] | Acetate dialysis |
Mancini et al. [49] | Compares LVH vs no LVH – no comparison of dialysis techniques |
Marcen et al. [50] | Acetate dialysis |
Marcen et al. [51] | Same data as Orfino 1990 |
Orfino et al. [52] | Acetate dialysis |
Panzetta et al. [53] | Thermal changes only outcome measured |
Picca et al. [54] | Acetate dialysis |
Pizzarelli et al. [55] | Haemofiltration only |
Provenzano et al. [56] | Pilot study, thermal changes only outcome measured |
Quereda et al. [57] | Acetate dialysis |
Rosales et al. [58] | Additional intervention of exercise during dialysis |
Rosales et al. [59] | Thermal changes only outcome measured |
Schaefer, Von and Hufler [60] | Haemofiltration only |
Schneditz et al. [61] | Thermal changes only outcome measured |
Sherman et al. [62] | Acetate dialysis |
Sherman et al. [63] | Acetate dialysis |
van Der Sande et al. [64] | Insufficient data (abstract) |
van Kuijk et al. [65] | Incompatible data—HD assessed before and after periods of ultrafiltration |
van Kuijk et al. [66] | Uses haemofiltration in intervention arm |
van Kuijk et al. [67] | Same data as van Kuijk et al. [66] |
Study ID . | Reason for exclusion . |
---|---|
Aizawa et al. [28] | Ex vivo |
Alappan et al. [29] | Additional intervention—Ca2+ concentration in dialysate adjusted |
Bazzato et al. [30] | Same data as Bazzato et al. [31] |
Bazzato et al. [31] | Acetate dialysis |
Beerenhout et al. [32] | Ex vivo |
Coli et al. [33] | Sama data as Bazzato et al. [31] |
Daugirdas [34] | Not specific comparison of cool dialysis vs standard |
Decheva et al. [35] | Not specific comparison of cool dialysis vs standard |
Donauer et al. [36] | Compared isothermic dialysis and haemodiafiltration |
Gotch, Keen and Yarian [37] | Theoretical modelling for thermal balance |
Hegbrant et al. [38] | Same data as Hegbrant et al. [20] ASAIO J |
Karamperis, Sloth and Jensen [39] | Compared isothermic dialysis and haemodiafiltration |
Keijman et al. [40] | Thermal changes only outcome measured |
Kerr, Van and Dawborn [41] | Acetate dialysis |
Kuhlmann and Hermann[42] | Insufficient data (abstract) |
Lindholm et al. [4] | Acetate dialysis |
Maggiore et al. [3] | Acetate dialysis |
Maggiore et al. [43] | Acetate dialysis |
Maggiore et al. [44] | Review |
Maggiore et al. [45] | Same data as Maggiore et al. [3] |
Maggiore et al. [46] | Review |
Maggiore [47] | Insufficient data (abstract) |
Mahida et al. [48] | Acetate dialysis |
Mancini et al. [49] | Compares LVH vs no LVH – no comparison of dialysis techniques |
Marcen et al. [50] | Acetate dialysis |
Marcen et al. [51] | Same data as Orfino 1990 |
Orfino et al. [52] | Acetate dialysis |
Panzetta et al. [53] | Thermal changes only outcome measured |
Picca et al. [54] | Acetate dialysis |
Pizzarelli et al. [55] | Haemofiltration only |
Provenzano et al. [56] | Pilot study, thermal changes only outcome measured |
Quereda et al. [57] | Acetate dialysis |
Rosales et al. [58] | Additional intervention of exercise during dialysis |
Rosales et al. [59] | Thermal changes only outcome measured |
Schaefer, Von and Hufler [60] | Haemofiltration only |
Schneditz et al. [61] | Thermal changes only outcome measured |
Sherman et al. [62] | Acetate dialysis |
Sherman et al. [63] | Acetate dialysis |
van Der Sande et al. [64] | Insufficient data (abstract) |
van Kuijk et al. [65] | Incompatible data—HD assessed before and after periods of ultrafiltration |
van Kuijk et al. [66] | Uses haemofiltration in intervention arm |
van Kuijk et al. [67] | Same data as van Kuijk et al. [66] |
Study ID . | Reason for exclusion . |
---|---|
Aizawa et al. [28] | Ex vivo |
Alappan et al. [29] | Additional intervention—Ca2+ concentration in dialysate adjusted |
Bazzato et al. [30] | Same data as Bazzato et al. [31] |
Bazzato et al. [31] | Acetate dialysis |
Beerenhout et al. [32] | Ex vivo |
Coli et al. [33] | Sama data as Bazzato et al. [31] |
Daugirdas [34] | Not specific comparison of cool dialysis vs standard |
Decheva et al. [35] | Not specific comparison of cool dialysis vs standard |
Donauer et al. [36] | Compared isothermic dialysis and haemodiafiltration |
Gotch, Keen and Yarian [37] | Theoretical modelling for thermal balance |
Hegbrant et al. [38] | Same data as Hegbrant et al. [20] ASAIO J |
Karamperis, Sloth and Jensen [39] | Compared isothermic dialysis and haemodiafiltration |
Keijman et al. [40] | Thermal changes only outcome measured |
Kerr, Van and Dawborn [41] | Acetate dialysis |
Kuhlmann and Hermann[42] | Insufficient data (abstract) |
Lindholm et al. [4] | Acetate dialysis |
Maggiore et al. [3] | Acetate dialysis |
Maggiore et al. [43] | Acetate dialysis |
Maggiore et al. [44] | Review |
Maggiore et al. [45] | Same data as Maggiore et al. [3] |
Maggiore et al. [46] | Review |
Maggiore [47] | Insufficient data (abstract) |
Mahida et al. [48] | Acetate dialysis |
Mancini et al. [49] | Compares LVH vs no LVH – no comparison of dialysis techniques |
Marcen et al. [50] | Acetate dialysis |
Marcen et al. [51] | Same data as Orfino 1990 |
Orfino et al. [52] | Acetate dialysis |
Panzetta et al. [53] | Thermal changes only outcome measured |
Picca et al. [54] | Acetate dialysis |
Pizzarelli et al. [55] | Haemofiltration only |
Provenzano et al. [56] | Pilot study, thermal changes only outcome measured |
Quereda et al. [57] | Acetate dialysis |
Rosales et al. [58] | Additional intervention of exercise during dialysis |
Rosales et al. [59] | Thermal changes only outcome measured |
Schaefer, Von and Hufler [60] | Haemofiltration only |
Schneditz et al. [61] | Thermal changes only outcome measured |
Sherman et al. [62] | Acetate dialysis |
Sherman et al. [63] | Acetate dialysis |
van Der Sande et al. [64] | Insufficient data (abstract) |
van Kuijk et al. [65] | Incompatible data—HD assessed before and after periods of ultrafiltration |
van Kuijk et al. [66] | Uses haemofiltration in intervention arm |
van Kuijk et al. [67] | Same data as van Kuijk et al. [66] |
Study ID . | Reason for exclusion . |
---|---|
Aizawa et al. [28] | Ex vivo |
Alappan et al. [29] | Additional intervention—Ca2+ concentration in dialysate adjusted |
Bazzato et al. [30] | Same data as Bazzato et al. [31] |
Bazzato et al. [31] | Acetate dialysis |
Beerenhout et al. [32] | Ex vivo |
Coli et al. [33] | Sama data as Bazzato et al. [31] |
Daugirdas [34] | Not specific comparison of cool dialysis vs standard |
Decheva et al. [35] | Not specific comparison of cool dialysis vs standard |
Donauer et al. [36] | Compared isothermic dialysis and haemodiafiltration |
Gotch, Keen and Yarian [37] | Theoretical modelling for thermal balance |
Hegbrant et al. [38] | Same data as Hegbrant et al. [20] ASAIO J |
Karamperis, Sloth and Jensen [39] | Compared isothermic dialysis and haemodiafiltration |
Keijman et al. [40] | Thermal changes only outcome measured |
Kerr, Van and Dawborn [41] | Acetate dialysis |
Kuhlmann and Hermann[42] | Insufficient data (abstract) |
Lindholm et al. [4] | Acetate dialysis |
Maggiore et al. [3] | Acetate dialysis |
Maggiore et al. [43] | Acetate dialysis |
Maggiore et al. [44] | Review |
Maggiore et al. [45] | Same data as Maggiore et al. [3] |
Maggiore et al. [46] | Review |
Maggiore [47] | Insufficient data (abstract) |
Mahida et al. [48] | Acetate dialysis |
Mancini et al. [49] | Compares LVH vs no LVH – no comparison of dialysis techniques |
Marcen et al. [50] | Acetate dialysis |
Marcen et al. [51] | Same data as Orfino 1990 |
Orfino et al. [52] | Acetate dialysis |
Panzetta et al. [53] | Thermal changes only outcome measured |
Picca et al. [54] | Acetate dialysis |
Pizzarelli et al. [55] | Haemofiltration only |
Provenzano et al. [56] | Pilot study, thermal changes only outcome measured |
Quereda et al. [57] | Acetate dialysis |
Rosales et al. [58] | Additional intervention of exercise during dialysis |
Rosales et al. [59] | Thermal changes only outcome measured |
Schaefer, Von and Hufler [60] | Haemofiltration only |
Schneditz et al. [61] | Thermal changes only outcome measured |
Sherman et al. [62] | Acetate dialysis |
Sherman et al. [63] | Acetate dialysis |
van Der Sande et al. [64] | Insufficient data (abstract) |
van Kuijk et al. [65] | Incompatible data—HD assessed before and after periods of ultrafiltration |
van Kuijk et al. [66] | Uses haemofiltration in intervention arm |
van Kuijk et al. [67] | Same data as van Kuijk et al. [66] |
Included studies
A total of 22 studies were included in the review with a total of 408 patients. These are summarized in Table 2. Twenty of these were published as journal articles, one was published as a letter [6] and one was in abstract form [7]. All had a crossover design.
Study ID . | Methods . | Participants . | Interventions . | Outcomes . | Comments . | Grading . | . | |
---|---|---|---|---|---|---|---|---|
. | . | . | . | . | . | Cochrane . | Jadad . | |
Ayoub and Finlayson [17] | Crossover | 10 | Fixed temperature 36.5°C | IDH | UF equal | B | 2 | |
No blinding | Age 59±5.5 | Fixed temperature 35.0°C | MAP | |||||
Duration 6 sessions | 5 stable, 5 unstable | Symptoms | ||||||
0 dropouts | URR | |||||||
Body temperature | ||||||||
Barendregt et al. [7] | Crossover | 9 | Fixed temperature 37.5°C | SBP | UF equal | B | 2 | |
Blinding unclear | Age 68±10 | Fixed temperature 35.5°C | Body temperature | |||||
Duration 2 sessions | Stability not stated | |||||||
0 dropouts | ||||||||
Beerenhout et al. [25] | Crossover | 12 | Fixed temperature 37.5°C | SBP | UF equal | B | 2 | |
Blinding unclear | Age 64.7±9 | BTM (prog cooling, mean dialysate temperature 35.2°C) | HR | Data SEMs | ||||
Duration 2 sessions | Stable | Body temperature | ||||||
0 dropouts | Vintage 26±20 months | Nitric oxide | ||||||
Beerenhout et al. [14] | Crossover | 12 | Fixed temperature 36.5°C | SBP | UF equal | C | 2 | |
Blinding unclear | Age 69±4 | Haemodynamics | ||||||
Duration 2 sessions | Stable | Fixed temperature 35.5°C | Body temperature | |||||
1 dropout – not ITT | ||||||||
Cruz et al. [15] | Crossover | 11 completed | Fixed temperature 37.0°C | IDH | UF equal | B | 2 | |
No blinding | Age 67.5 | SBP | ||||||
Duration 18 sessions | Unstable | Fixed temperature 35.0°C | Symptoms | |||||
8 dropouts – not ITT | 7 diabetics | Kt/V | ||||||
Dheenan and Henrich [8] | Crossover | 10 | Standard | IDH | UF equal | C | 2 | |
Single blinded | Age 61±12.5 | Fixed temperature 35.0°C | MAP | |||||
Duration 12 sessions | Unstable | Symptoms | ||||||
0 dropouts | 8 diabetics | URR | ||||||
Vintage 11–112 months | ||||||||
Fine and Penner [12] | Crossover | 73 | Fixed temperature 37.0°C | IDH | UF equal | C | 1 | |
Patient and providers blinded | Age 58 | Block (centre) randomization | ||||||
Some dropouts, no details, not ITT | Unselected for stability | Fixed temperature 35.0°C | Some pts studied>once | |||||
Duration 12 sessions | Excluded if body temperature 36.0–36.5°C | Unequal no. sessions in control and intervention | ||||||
Hegbrant et al. [20] | Crossover | 10 | Fixed temperature 38.5°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 63 | Body temperature | Data SEMs | |||||
Duration 2 sessions | Stable | Fixed temperature 34.5°C | Noradrenalin | |||||
0 dropouts | Vintage 3–49 months | |||||||
Hoeben et al. [21] | Crossover | 13 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 57.6±13.8 | Haemodynamics | Some pts studied > once | |||||
Duration 2 sessions | Unstable | Fixed temperature 35.5°C | ||||||
0 dropouts | All had LVEF <40% | |||||||
Jamil et al. [6] | Crossover | 7 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
No blinding | Age 53–75 | Symptoms | ||||||
Duration 2 sessions | Unstable | Fixed temperature 35.5°C | Nitric oxide | |||||
0 dropouts | Vintage 22–336 months | |||||||
Jost et al. [11] | Crossover | 12 | Fixed temperature 37.0°C | IDH | UF equal | A | 4 | |
Double blinded | Age 62.5±3.6 | MAP | ||||||
Duration 2 sessions | Unstable | Fixed temperature 35.0°C | Haemodynamics | |||||
0 dropouts | Noradrenalin | |||||||
Kaufman et al. [19] | Crossover | 15 patients | BTM | IDH | UF equal | C | 2 | |
Blinding unclear | Age 56±19 | thermoneutral | MAP, SBP Haemodynamics | 11 patients studied twice | ||||
Duration 2–4 sessions | Stability not stated | (dialysate temperature 37.1) | Kt/V | Data SEMs | ||||
0 dropouts | BTM negative energy (dialysate temperature 35.7) | Body temperature | ||||||
Kishimoto et al. [9] | Crossover | 9 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 39–60 | Fixed temperature 34.0°C | HR | Dialysis 1 h Duration | ||||
Duration 2 sessions | Stable | Haemodynamics | Room cooled in intervention arm | |||||
0 dropouts | Noradrenalin | |||||||
Levin et al. [27] | Crossover | 9 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Stability not stated | BTM (prog cooling by 0.2°C) | Haemodynamics | Few details re pt demographics | ||||
Duration 2 sessions | Kt/V | |||||||
0 dorpouts | Body temperature | |||||||
Levy et al. [22] | Crossover | 6 | Fixed temperature 37.0°C | MAP | UF equal | B | 3 | |
Patient and providers blinded | Age 55±11 | Fixed temperature 35.0°C | Body temperature | LV contractility also assessed | ||||
Duration 2 sessions | Stable | Noradrenalin | ||||||
0 dropouts | Vintage 71±58 months | |||||||
Maggiore et al. [16] | Crossover | 95 completed | BTM thermoneutral | IDH | UF equal | B | 2 | |
No blinding | Age 66±12 | BTM isothermic | SBP | High dropout rate but described | ||||
Duration 24 sessions | Unstable | HR | ||||||
21 dropouts – not ITT | Vintage >3 month | Kt/V | ||||||
25% diabetes | Symptoms | |||||||
Schneditz et al. [23] | Crossover | 8 | BTM (slightly negative energy, dialysate temperature 37.3°C) | SBP, MAP | UF equal | B | 2 | |
Blinding unclear | Age 54–79 | BTM (moderate negative energy, dialysate temperature 35.3°C) | Body temperature | |||||
Duration 2 sessions | Stability not stated | |||||||
0 dropouts | ||||||||
van Der Sande et al. [18] | Crossover | 9 | Fixed temperature 37.5°C | IDH | UF equal | B | 2 | |
Single blinded | Age 68.7±10.4 | Fixed temperature 35.5°C | SBP | |||||
Duration 2 sessions | 6 stable, 3 unstable | Body temperature | ||||||
0 dropouts | ||||||||
van Der Sande et al. [10] | Crossover | 15 | Fixed temperature 37.5°C | SBP, MAP | UF equal | B | 2 | |
Blinding unclear | Age 21–77 | Fixed temperature 35.5°C | Symptoms | Dialysis 1 hr duration | ||||
Duration 4 sessions | Stability not stated | Body temperature | ||||||
0 dropouts | Vintage 4–252 months | Haemodynamics | ||||||
van Der Sande et al. [24] | Crossover | 12 | Fixed temperature 37.5°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 56.7±16 | Fixed temperature 35.5°C | Body temperature | |||||
Duration 4 sessions | Stable | |||||||
0 dropouts | Vintage 48±42 months | |||||||
van Der Sande et al. [26] | Crossover | 13 | BTM thermoneutral | Haemodynamics | UF equal | B | 2 | |
Blinding unclear | Stable | BTM isothermic | Body temperature | |||||
Duration 4 sessions | ||||||||
0 dropouts | ||||||||
Yu et al. [13] | Crossover | 9 | Fixed temperature 37.5°C | MAP | UF equal | B | 2 | |
Single blinded | Age 63±6.6 | Fixed temperature 35.0°C | HR | |||||
Duration 4 sessions | Stability not stated | Haemodynamics | ||||||
0 dropouts | KT/V | |||||||
Body temperature |
Study ID . | Methods . | Participants . | Interventions . | Outcomes . | Comments . | Grading . | . | |
---|---|---|---|---|---|---|---|---|
. | . | . | . | . | . | Cochrane . | Jadad . | |
Ayoub and Finlayson [17] | Crossover | 10 | Fixed temperature 36.5°C | IDH | UF equal | B | 2 | |
No blinding | Age 59±5.5 | Fixed temperature 35.0°C | MAP | |||||
Duration 6 sessions | 5 stable, 5 unstable | Symptoms | ||||||
0 dropouts | URR | |||||||
Body temperature | ||||||||
Barendregt et al. [7] | Crossover | 9 | Fixed temperature 37.5°C | SBP | UF equal | B | 2 | |
Blinding unclear | Age 68±10 | Fixed temperature 35.5°C | Body temperature | |||||
Duration 2 sessions | Stability not stated | |||||||
0 dropouts | ||||||||
Beerenhout et al. [25] | Crossover | 12 | Fixed temperature 37.5°C | SBP | UF equal | B | 2 | |
Blinding unclear | Age 64.7±9 | BTM (prog cooling, mean dialysate temperature 35.2°C) | HR | Data SEMs | ||||
Duration 2 sessions | Stable | Body temperature | ||||||
0 dropouts | Vintage 26±20 months | Nitric oxide | ||||||
Beerenhout et al. [14] | Crossover | 12 | Fixed temperature 36.5°C | SBP | UF equal | C | 2 | |
Blinding unclear | Age 69±4 | Haemodynamics | ||||||
Duration 2 sessions | Stable | Fixed temperature 35.5°C | Body temperature | |||||
1 dropout – not ITT | ||||||||
Cruz et al. [15] | Crossover | 11 completed | Fixed temperature 37.0°C | IDH | UF equal | B | 2 | |
No blinding | Age 67.5 | SBP | ||||||
Duration 18 sessions | Unstable | Fixed temperature 35.0°C | Symptoms | |||||
8 dropouts – not ITT | 7 diabetics | Kt/V | ||||||
Dheenan and Henrich [8] | Crossover | 10 | Standard | IDH | UF equal | C | 2 | |
Single blinded | Age 61±12.5 | Fixed temperature 35.0°C | MAP | |||||
Duration 12 sessions | Unstable | Symptoms | ||||||
0 dropouts | 8 diabetics | URR | ||||||
Vintage 11–112 months | ||||||||
Fine and Penner [12] | Crossover | 73 | Fixed temperature 37.0°C | IDH | UF equal | C | 1 | |
Patient and providers blinded | Age 58 | Block (centre) randomization | ||||||
Some dropouts, no details, not ITT | Unselected for stability | Fixed temperature 35.0°C | Some pts studied>once | |||||
Duration 12 sessions | Excluded if body temperature 36.0–36.5°C | Unequal no. sessions in control and intervention | ||||||
Hegbrant et al. [20] | Crossover | 10 | Fixed temperature 38.5°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 63 | Body temperature | Data SEMs | |||||
Duration 2 sessions | Stable | Fixed temperature 34.5°C | Noradrenalin | |||||
0 dropouts | Vintage 3–49 months | |||||||
Hoeben et al. [21] | Crossover | 13 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 57.6±13.8 | Haemodynamics | Some pts studied > once | |||||
Duration 2 sessions | Unstable | Fixed temperature 35.5°C | ||||||
0 dropouts | All had LVEF <40% | |||||||
Jamil et al. [6] | Crossover | 7 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
No blinding | Age 53–75 | Symptoms | ||||||
Duration 2 sessions | Unstable | Fixed temperature 35.5°C | Nitric oxide | |||||
0 dropouts | Vintage 22–336 months | |||||||
Jost et al. [11] | Crossover | 12 | Fixed temperature 37.0°C | IDH | UF equal | A | 4 | |
Double blinded | Age 62.5±3.6 | MAP | ||||||
Duration 2 sessions | Unstable | Fixed temperature 35.0°C | Haemodynamics | |||||
0 dropouts | Noradrenalin | |||||||
Kaufman et al. [19] | Crossover | 15 patients | BTM | IDH | UF equal | C | 2 | |
Blinding unclear | Age 56±19 | thermoneutral | MAP, SBP Haemodynamics | 11 patients studied twice | ||||
Duration 2–4 sessions | Stability not stated | (dialysate temperature 37.1) | Kt/V | Data SEMs | ||||
0 dropouts | BTM negative energy (dialysate temperature 35.7) | Body temperature | ||||||
Kishimoto et al. [9] | Crossover | 9 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 39–60 | Fixed temperature 34.0°C | HR | Dialysis 1 h Duration | ||||
Duration 2 sessions | Stable | Haemodynamics | Room cooled in intervention arm | |||||
0 dropouts | Noradrenalin | |||||||
Levin et al. [27] | Crossover | 9 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Stability not stated | BTM (prog cooling by 0.2°C) | Haemodynamics | Few details re pt demographics | ||||
Duration 2 sessions | Kt/V | |||||||
0 dorpouts | Body temperature | |||||||
Levy et al. [22] | Crossover | 6 | Fixed temperature 37.0°C | MAP | UF equal | B | 3 | |
Patient and providers blinded | Age 55±11 | Fixed temperature 35.0°C | Body temperature | LV contractility also assessed | ||||
Duration 2 sessions | Stable | Noradrenalin | ||||||
0 dropouts | Vintage 71±58 months | |||||||
Maggiore et al. [16] | Crossover | 95 completed | BTM thermoneutral | IDH | UF equal | B | 2 | |
No blinding | Age 66±12 | BTM isothermic | SBP | High dropout rate but described | ||||
Duration 24 sessions | Unstable | HR | ||||||
21 dropouts – not ITT | Vintage >3 month | Kt/V | ||||||
25% diabetes | Symptoms | |||||||
Schneditz et al. [23] | Crossover | 8 | BTM (slightly negative energy, dialysate temperature 37.3°C) | SBP, MAP | UF equal | B | 2 | |
Blinding unclear | Age 54–79 | BTM (moderate negative energy, dialysate temperature 35.3°C) | Body temperature | |||||
Duration 2 sessions | Stability not stated | |||||||
0 dropouts | ||||||||
van Der Sande et al. [18] | Crossover | 9 | Fixed temperature 37.5°C | IDH | UF equal | B | 2 | |
Single blinded | Age 68.7±10.4 | Fixed temperature 35.5°C | SBP | |||||
Duration 2 sessions | 6 stable, 3 unstable | Body temperature | ||||||
0 dropouts | ||||||||
van Der Sande et al. [10] | Crossover | 15 | Fixed temperature 37.5°C | SBP, MAP | UF equal | B | 2 | |
Blinding unclear | Age 21–77 | Fixed temperature 35.5°C | Symptoms | Dialysis 1 hr duration | ||||
Duration 4 sessions | Stability not stated | Body temperature | ||||||
0 dropouts | Vintage 4–252 months | Haemodynamics | ||||||
van Der Sande et al. [24] | Crossover | 12 | Fixed temperature 37.5°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 56.7±16 | Fixed temperature 35.5°C | Body temperature | |||||
Duration 4 sessions | Stable | |||||||
0 dropouts | Vintage 48±42 months | |||||||
van Der Sande et al. [26] | Crossover | 13 | BTM thermoneutral | Haemodynamics | UF equal | B | 2 | |
Blinding unclear | Stable | BTM isothermic | Body temperature | |||||
Duration 4 sessions | ||||||||
0 dropouts | ||||||||
Yu et al. [13] | Crossover | 9 | Fixed temperature 37.5°C | MAP | UF equal | B | 2 | |
Single blinded | Age 63±6.6 | Fixed temperature 35.0°C | HR | |||||
Duration 4 sessions | Stability not stated | Haemodynamics | ||||||
0 dropouts | KT/V | |||||||
Body temperature |
SEMs, standard error of mean; ITT, intention to treat; temp, temperature; IDH, intradialytic hypotension; MAP, mean arterial pressure; URR, urea reduction ratio; UF, ultrafiltration volume; SBP, systolic blood pressure; HR, heart rate; LVEF, left ventricular ejection fraction; vintage, time on dialysis in months; BTM, (biofeedback) blood temperature monitor.
Study ID . | Methods . | Participants . | Interventions . | Outcomes . | Comments . | Grading . | . | |
---|---|---|---|---|---|---|---|---|
. | . | . | . | . | . | Cochrane . | Jadad . | |
Ayoub and Finlayson [17] | Crossover | 10 | Fixed temperature 36.5°C | IDH | UF equal | B | 2 | |
No blinding | Age 59±5.5 | Fixed temperature 35.0°C | MAP | |||||
Duration 6 sessions | 5 stable, 5 unstable | Symptoms | ||||||
0 dropouts | URR | |||||||
Body temperature | ||||||||
Barendregt et al. [7] | Crossover | 9 | Fixed temperature 37.5°C | SBP | UF equal | B | 2 | |
Blinding unclear | Age 68±10 | Fixed temperature 35.5°C | Body temperature | |||||
Duration 2 sessions | Stability not stated | |||||||
0 dropouts | ||||||||
Beerenhout et al. [25] | Crossover | 12 | Fixed temperature 37.5°C | SBP | UF equal | B | 2 | |
Blinding unclear | Age 64.7±9 | BTM (prog cooling, mean dialysate temperature 35.2°C) | HR | Data SEMs | ||||
Duration 2 sessions | Stable | Body temperature | ||||||
0 dropouts | Vintage 26±20 months | Nitric oxide | ||||||
Beerenhout et al. [14] | Crossover | 12 | Fixed temperature 36.5°C | SBP | UF equal | C | 2 | |
Blinding unclear | Age 69±4 | Haemodynamics | ||||||
Duration 2 sessions | Stable | Fixed temperature 35.5°C | Body temperature | |||||
1 dropout – not ITT | ||||||||
Cruz et al. [15] | Crossover | 11 completed | Fixed temperature 37.0°C | IDH | UF equal | B | 2 | |
No blinding | Age 67.5 | SBP | ||||||
Duration 18 sessions | Unstable | Fixed temperature 35.0°C | Symptoms | |||||
8 dropouts – not ITT | 7 diabetics | Kt/V | ||||||
Dheenan and Henrich [8] | Crossover | 10 | Standard | IDH | UF equal | C | 2 | |
Single blinded | Age 61±12.5 | Fixed temperature 35.0°C | MAP | |||||
Duration 12 sessions | Unstable | Symptoms | ||||||
0 dropouts | 8 diabetics | URR | ||||||
Vintage 11–112 months | ||||||||
Fine and Penner [12] | Crossover | 73 | Fixed temperature 37.0°C | IDH | UF equal | C | 1 | |
Patient and providers blinded | Age 58 | Block (centre) randomization | ||||||
Some dropouts, no details, not ITT | Unselected for stability | Fixed temperature 35.0°C | Some pts studied>once | |||||
Duration 12 sessions | Excluded if body temperature 36.0–36.5°C | Unequal no. sessions in control and intervention | ||||||
Hegbrant et al. [20] | Crossover | 10 | Fixed temperature 38.5°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 63 | Body temperature | Data SEMs | |||||
Duration 2 sessions | Stable | Fixed temperature 34.5°C | Noradrenalin | |||||
0 dropouts | Vintage 3–49 months | |||||||
Hoeben et al. [21] | Crossover | 13 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 57.6±13.8 | Haemodynamics | Some pts studied > once | |||||
Duration 2 sessions | Unstable | Fixed temperature 35.5°C | ||||||
0 dropouts | All had LVEF <40% | |||||||
Jamil et al. [6] | Crossover | 7 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
No blinding | Age 53–75 | Symptoms | ||||||
Duration 2 sessions | Unstable | Fixed temperature 35.5°C | Nitric oxide | |||||
0 dropouts | Vintage 22–336 months | |||||||
Jost et al. [11] | Crossover | 12 | Fixed temperature 37.0°C | IDH | UF equal | A | 4 | |
Double blinded | Age 62.5±3.6 | MAP | ||||||
Duration 2 sessions | Unstable | Fixed temperature 35.0°C | Haemodynamics | |||||
0 dropouts | Noradrenalin | |||||||
Kaufman et al. [19] | Crossover | 15 patients | BTM | IDH | UF equal | C | 2 | |
Blinding unclear | Age 56±19 | thermoneutral | MAP, SBP Haemodynamics | 11 patients studied twice | ||||
Duration 2–4 sessions | Stability not stated | (dialysate temperature 37.1) | Kt/V | Data SEMs | ||||
0 dropouts | BTM negative energy (dialysate temperature 35.7) | Body temperature | ||||||
Kishimoto et al. [9] | Crossover | 9 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 39–60 | Fixed temperature 34.0°C | HR | Dialysis 1 h Duration | ||||
Duration 2 sessions | Stable | Haemodynamics | Room cooled in intervention arm | |||||
0 dropouts | Noradrenalin | |||||||
Levin et al. [27] | Crossover | 9 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Stability not stated | BTM (prog cooling by 0.2°C) | Haemodynamics | Few details re pt demographics | ||||
Duration 2 sessions | Kt/V | |||||||
0 dorpouts | Body temperature | |||||||
Levy et al. [22] | Crossover | 6 | Fixed temperature 37.0°C | MAP | UF equal | B | 3 | |
Patient and providers blinded | Age 55±11 | Fixed temperature 35.0°C | Body temperature | LV contractility also assessed | ||||
Duration 2 sessions | Stable | Noradrenalin | ||||||
0 dropouts | Vintage 71±58 months | |||||||
Maggiore et al. [16] | Crossover | 95 completed | BTM thermoneutral | IDH | UF equal | B | 2 | |
No blinding | Age 66±12 | BTM isothermic | SBP | High dropout rate but described | ||||
Duration 24 sessions | Unstable | HR | ||||||
21 dropouts – not ITT | Vintage >3 month | Kt/V | ||||||
25% diabetes | Symptoms | |||||||
Schneditz et al. [23] | Crossover | 8 | BTM (slightly negative energy, dialysate temperature 37.3°C) | SBP, MAP | UF equal | B | 2 | |
Blinding unclear | Age 54–79 | BTM (moderate negative energy, dialysate temperature 35.3°C) | Body temperature | |||||
Duration 2 sessions | Stability not stated | |||||||
0 dropouts | ||||||||
van Der Sande et al. [18] | Crossover | 9 | Fixed temperature 37.5°C | IDH | UF equal | B | 2 | |
Single blinded | Age 68.7±10.4 | Fixed temperature 35.5°C | SBP | |||||
Duration 2 sessions | 6 stable, 3 unstable | Body temperature | ||||||
0 dropouts | ||||||||
van Der Sande et al. [10] | Crossover | 15 | Fixed temperature 37.5°C | SBP, MAP | UF equal | B | 2 | |
Blinding unclear | Age 21–77 | Fixed temperature 35.5°C | Symptoms | Dialysis 1 hr duration | ||||
Duration 4 sessions | Stability not stated | Body temperature | ||||||
0 dropouts | Vintage 4–252 months | Haemodynamics | ||||||
van Der Sande et al. [24] | Crossover | 12 | Fixed temperature 37.5°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 56.7±16 | Fixed temperature 35.5°C | Body temperature | |||||
Duration 4 sessions | Stable | |||||||
0 dropouts | Vintage 48±42 months | |||||||
van Der Sande et al. [26] | Crossover | 13 | BTM thermoneutral | Haemodynamics | UF equal | B | 2 | |
Blinding unclear | Stable | BTM isothermic | Body temperature | |||||
Duration 4 sessions | ||||||||
0 dropouts | ||||||||
Yu et al. [13] | Crossover | 9 | Fixed temperature 37.5°C | MAP | UF equal | B | 2 | |
Single blinded | Age 63±6.6 | Fixed temperature 35.0°C | HR | |||||
Duration 4 sessions | Stability not stated | Haemodynamics | ||||||
0 dropouts | KT/V | |||||||
Body temperature |
Study ID . | Methods . | Participants . | Interventions . | Outcomes . | Comments . | Grading . | . | |
---|---|---|---|---|---|---|---|---|
. | . | . | . | . | . | Cochrane . | Jadad . | |
Ayoub and Finlayson [17] | Crossover | 10 | Fixed temperature 36.5°C | IDH | UF equal | B | 2 | |
No blinding | Age 59±5.5 | Fixed temperature 35.0°C | MAP | |||||
Duration 6 sessions | 5 stable, 5 unstable | Symptoms | ||||||
0 dropouts | URR | |||||||
Body temperature | ||||||||
Barendregt et al. [7] | Crossover | 9 | Fixed temperature 37.5°C | SBP | UF equal | B | 2 | |
Blinding unclear | Age 68±10 | Fixed temperature 35.5°C | Body temperature | |||||
Duration 2 sessions | Stability not stated | |||||||
0 dropouts | ||||||||
Beerenhout et al. [25] | Crossover | 12 | Fixed temperature 37.5°C | SBP | UF equal | B | 2 | |
Blinding unclear | Age 64.7±9 | BTM (prog cooling, mean dialysate temperature 35.2°C) | HR | Data SEMs | ||||
Duration 2 sessions | Stable | Body temperature | ||||||
0 dropouts | Vintage 26±20 months | Nitric oxide | ||||||
Beerenhout et al. [14] | Crossover | 12 | Fixed temperature 36.5°C | SBP | UF equal | C | 2 | |
Blinding unclear | Age 69±4 | Haemodynamics | ||||||
Duration 2 sessions | Stable | Fixed temperature 35.5°C | Body temperature | |||||
1 dropout – not ITT | ||||||||
Cruz et al. [15] | Crossover | 11 completed | Fixed temperature 37.0°C | IDH | UF equal | B | 2 | |
No blinding | Age 67.5 | SBP | ||||||
Duration 18 sessions | Unstable | Fixed temperature 35.0°C | Symptoms | |||||
8 dropouts – not ITT | 7 diabetics | Kt/V | ||||||
Dheenan and Henrich [8] | Crossover | 10 | Standard | IDH | UF equal | C | 2 | |
Single blinded | Age 61±12.5 | Fixed temperature 35.0°C | MAP | |||||
Duration 12 sessions | Unstable | Symptoms | ||||||
0 dropouts | 8 diabetics | URR | ||||||
Vintage 11–112 months | ||||||||
Fine and Penner [12] | Crossover | 73 | Fixed temperature 37.0°C | IDH | UF equal | C | 1 | |
Patient and providers blinded | Age 58 | Block (centre) randomization | ||||||
Some dropouts, no details, not ITT | Unselected for stability | Fixed temperature 35.0°C | Some pts studied>once | |||||
Duration 12 sessions | Excluded if body temperature 36.0–36.5°C | Unequal no. sessions in control and intervention | ||||||
Hegbrant et al. [20] | Crossover | 10 | Fixed temperature 38.5°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 63 | Body temperature | Data SEMs | |||||
Duration 2 sessions | Stable | Fixed temperature 34.5°C | Noradrenalin | |||||
0 dropouts | Vintage 3–49 months | |||||||
Hoeben et al. [21] | Crossover | 13 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 57.6±13.8 | Haemodynamics | Some pts studied > once | |||||
Duration 2 sessions | Unstable | Fixed temperature 35.5°C | ||||||
0 dropouts | All had LVEF <40% | |||||||
Jamil et al. [6] | Crossover | 7 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
No blinding | Age 53–75 | Symptoms | ||||||
Duration 2 sessions | Unstable | Fixed temperature 35.5°C | Nitric oxide | |||||
0 dropouts | Vintage 22–336 months | |||||||
Jost et al. [11] | Crossover | 12 | Fixed temperature 37.0°C | IDH | UF equal | A | 4 | |
Double blinded | Age 62.5±3.6 | MAP | ||||||
Duration 2 sessions | Unstable | Fixed temperature 35.0°C | Haemodynamics | |||||
0 dropouts | Noradrenalin | |||||||
Kaufman et al. [19] | Crossover | 15 patients | BTM | IDH | UF equal | C | 2 | |
Blinding unclear | Age 56±19 | thermoneutral | MAP, SBP Haemodynamics | 11 patients studied twice | ||||
Duration 2–4 sessions | Stability not stated | (dialysate temperature 37.1) | Kt/V | Data SEMs | ||||
0 dropouts | BTM negative energy (dialysate temperature 35.7) | Body temperature | ||||||
Kishimoto et al. [9] | Crossover | 9 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 39–60 | Fixed temperature 34.0°C | HR | Dialysis 1 h Duration | ||||
Duration 2 sessions | Stable | Haemodynamics | Room cooled in intervention arm | |||||
0 dropouts | Noradrenalin | |||||||
Levin et al. [27] | Crossover | 9 | Fixed temperature 37.0°C | MAP | UF equal | B | 2 | |
Blinding unclear | Stability not stated | BTM (prog cooling by 0.2°C) | Haemodynamics | Few details re pt demographics | ||||
Duration 2 sessions | Kt/V | |||||||
0 dorpouts | Body temperature | |||||||
Levy et al. [22] | Crossover | 6 | Fixed temperature 37.0°C | MAP | UF equal | B | 3 | |
Patient and providers blinded | Age 55±11 | Fixed temperature 35.0°C | Body temperature | LV contractility also assessed | ||||
Duration 2 sessions | Stable | Noradrenalin | ||||||
0 dropouts | Vintage 71±58 months | |||||||
Maggiore et al. [16] | Crossover | 95 completed | BTM thermoneutral | IDH | UF equal | B | 2 | |
No blinding | Age 66±12 | BTM isothermic | SBP | High dropout rate but described | ||||
Duration 24 sessions | Unstable | HR | ||||||
21 dropouts – not ITT | Vintage >3 month | Kt/V | ||||||
25% diabetes | Symptoms | |||||||
Schneditz et al. [23] | Crossover | 8 | BTM (slightly negative energy, dialysate temperature 37.3°C) | SBP, MAP | UF equal | B | 2 | |
Blinding unclear | Age 54–79 | BTM (moderate negative energy, dialysate temperature 35.3°C) | Body temperature | |||||
Duration 2 sessions | Stability not stated | |||||||
0 dropouts | ||||||||
van Der Sande et al. [18] | Crossover | 9 | Fixed temperature 37.5°C | IDH | UF equal | B | 2 | |
Single blinded | Age 68.7±10.4 | Fixed temperature 35.5°C | SBP | |||||
Duration 2 sessions | 6 stable, 3 unstable | Body temperature | ||||||
0 dropouts | ||||||||
van Der Sande et al. [10] | Crossover | 15 | Fixed temperature 37.5°C | SBP, MAP | UF equal | B | 2 | |
Blinding unclear | Age 21–77 | Fixed temperature 35.5°C | Symptoms | Dialysis 1 hr duration | ||||
Duration 4 sessions | Stability not stated | Body temperature | ||||||
0 dropouts | Vintage 4–252 months | Haemodynamics | ||||||
van Der Sande et al. [24] | Crossover | 12 | Fixed temperature 37.5°C | MAP | UF equal | B | 2 | |
Blinding unclear | Age 56.7±16 | Fixed temperature 35.5°C | Body temperature | |||||
Duration 4 sessions | Stable | |||||||
0 dropouts | Vintage 48±42 months | |||||||
van Der Sande et al. [26] | Crossover | 13 | BTM thermoneutral | Haemodynamics | UF equal | B | 2 | |
Blinding unclear | Stable | BTM isothermic | Body temperature | |||||
Duration 4 sessions | ||||||||
0 dropouts | ||||||||
Yu et al. [13] | Crossover | 9 | Fixed temperature 37.5°C | MAP | UF equal | B | 2 | |
Single blinded | Age 63±6.6 | Fixed temperature 35.0°C | HR | |||||
Duration 4 sessions | Stability not stated | Haemodynamics | ||||||
0 dropouts | KT/V | |||||||
Body temperature |
SEMs, standard error of mean; ITT, intention to treat; temp, temperature; IDH, intradialytic hypotension; MAP, mean arterial pressure; URR, urea reduction ratio; UF, ultrafiltration volume; SBP, systolic blood pressure; HR, heart rate; LVEF, left ventricular ejection fraction; vintage, time on dialysis in months; BTM, (biofeedback) blood temperature monitor.
Sixteen studies (235 patients) examined dialysis with a fixed, empirical reduction in dialysis temperature. In the control arm of the study, standard dialysate temperature varied between studies with one study selecting 38.5°C, five studies selecting 37.5°C, seven studies selecting 37.0°C and two studies selecting 36.5°C. One study did not state the temperature in the control arm [8]. Cool-dialysis temperature also varied with seven studies using 35.5°C, seven studies using 35.0°C and one study each using 34.5°C and 34.0°C.
Six studies (173 patients) examined dialysis with BTM (either programmed cooling or isothermic dialysis). Again there was a variation in the control and intervention. For the control arm, one study used a fixed dialysate temperature of 37.5°C, one study used a fixed dialysate temperature of 37.0°C, three studies used thermoneutral dialysis and one study used ‘mildly negative energy transfer’ (mean dialysate temperature 37.3°C). For the intervention phase, three studies used programmed cooling (mean dialysate temperatures 35.7, 35.3 and 35.2°C) and two studies used isothermic dialysis.
No studies were identified that compared a fixed reduction in dialysate temperature with biofeedback temperature control.
The baseline stability during dialysis of the studied patients also varied. Seven studies examined stable patients, five studies examined unstable patients, four papers included a mix of stable and unstable patients and six studies did not clearly state the patients’ susceptibility to IDH.
Study duration was two dialysis sessions in 13 studies, four sessions in four studies, and one study each had a duration of 6, 12, 18, 20 and 24 sessions. No studies reported mortality as an outcome measure.
All included studies reported that there were no differences in ultrafiltration volume between the control and the intervention arms. In 20 studies, the dialysis duration was ‘standard’ (approximately 4 h) but in two studies, the dialysis duration was only 1 h [9,10]. One study had a higher dialysate sodium conductivity in the cool-temperature arm [8].
Methodological quality
Allocation concealment of the studies was assessed using the Cochrane scoring system. Twenty-one of the included studies had a score of either grade B (unclear concealment) or C (inadequate concealment). Only one study was scored as grade A (adequate concealment) [11]. On the Jadad scoring method, one paper each had a score of 1, 3 and 4, while the remaining 19 had a score of 2. Although randomization was almost universally adequate, most studies did not use blinding. Of those that did use blinding, three studies used single blinding only, two blinded both participants and providers and only one had adequate double blinding. However, in two of the studies that did use blinding, ‘a significant proportion’ of patients (although numbers are not stated) were reported as able to detect the intervention because of a sensation of feeling cooler than usual [12,13].
Most of the studies were short-term and therefore did not have any dropouts. Of those that did have dropouts [12,14–16], all analysed the data from only the patients who completed the study. This approach may have exposed the results to possible attrition bias, although in small cross-over studies it could be argued that including unpaired data could also be misleading. Two of these studies had good descriptions of the characteristics of the dropouts [15,16], and Maggiore et al. [16] demonstrated no difference between the baseline characteristics of the dropouts and completers.
Outcome measures
Intradialytic hypotension
Six studies reported the effect of fixed reduction of dialysate temperature on IDH frequency [8,11,12,15,17,18], and a further two described the effect of BTM [16,19]. Of the two studies examining BTM, one employed programmed cooling whilst the other used isothermic dialysis. All of these studies reported a significant reduction in IDH frequency with reduction in dialysate temperature. Pooling all studies, the rate of IDH with standard dialysis was 7.1 (95% CI, 5.3–8.9) times greater than with cool dialysis. For cool dialysis with a fixed reduction in temperature, the rate of IDH was 9.5 (95% CI, 6.7–12.4) times less than standard HD, and for BTM the IDH rate was 2.0 (95% CI, 1.9–2.1) times less than control. Two studies reported 0 episodes of IDH in the intervention group [11,17] resulting in very large rate ratios. When these two studies were removed from the analysis, there was still a significant benefit observed with cool dialysis, with the rate of IDH being 2.6 (95% CI, 1.5–3.8) times less than that with standard dialysis. These data are summarized in Figure 1.
Four of the trials reporting only IDH studied patients prone to intradialytic instability [8,11,15,16]. In the study by Ayoub and Finlayson [17], which examined a mix of stable and unstable patients, all of the episodes of IDH occurred in the unstable group. van Der Sande et al. [18] did not perform a subgroup analysis to differentiate between unstable and stable patients. There were no studies that reported the rate of IDH frequency in stable patients only. Fine and Penner [12] observed that the IDH rate for a randomly unselected dialysis population was reduced by cooling the dialysate, but found that this effect was predominantly due to the protective effect on those patients with a low (<36°C) pre-dialysis core temperature. However, this study did have several methodological weaknesses (Table 2).
Blood pressure
BP was reported in four different ways across the studies; pre- and post-systolic blood pressure (SBP), delta SBP, pre- and post-mean arterial pressure (MAP) and delta MAP. In all of the studies reporting pre- and post-BP readings, the BP at the start of dialysis was equal between control and intervention.
Ten studies reported pre- and post-MAP, eight with fixed temperature reduction [6,8,10,11,17,20–22] and two with BTM (both negative energy transfer) [19,23]. Pooled data for all studies showed higher post-dialysis MAP with cool dialysis (WMD of 11.3 mmHg, 95% CI 7.7–15.0). Although only four of the eight studies examining the effect of fixed temperature reduction independently reported a significantly higher post-dialysis MAP, the pooled results for these studies showed a post-dialysis MAP that was 12.0 mmHg (95% CI, 8.1–15.9) higher with cool dialysis. However, for BTM the results were less clear. Kaufman et al. [19] found a significantly higher post-dialysis MAP whereas Schneditz et al. [23] did not, despite similar magnitudes of cooling in each study. The pooled result for these two studies demonstrated a trend for higher post-dialysis MAP that did not reach statistical significance (WMD 6.2 mmHg, 95% CI −4.9–17.2). These data are summarized in Figure 2.
Delta MAP was reported in five studies that examined a fixed temperature reduction [6,9,13,21,24] and two that examined BTM (both negative energy transfer, similar degree of cooling) [19,23]. All five studies with fixed temperature reduction individually reported a significantly smaller drop in MAP with cool dialysis, and the pooled results also showed this effect (WMD 16.9 mmHg, 95% CI 12.9–20.8). For BTM, Kaufman et al. [19] found a significant benefit with cool dialysis whereas Schneditz et al. [23] did not; pooled results showed a non-significant trend for a smaller delta MAP (WMD 2.1 mmHg, 95% CI −0.7–4.9). Pooled results for all trials demonstrated a significantly smaller delta MAP with cool dialysis (WMD 7.1 mmHg, 95% CI, 4.9–9.4). These data are shown in Figure 3.
Post-dialysis SBP was reported in three studies examining fixed temperature reduction [10,15,18] and three that examined BTM (two with negative energy transfer, one with programmed cooling) [19,23,25]. One of the three studies with fixed temperature reduction independently reported a significantly higher post-dialysis SBP with cool dialysis [15], and the other two reported a non-significant trend for the same effect. Pooled results for these three trials demonstrated a significantly higher post-dialysis SBP with cool dialysis (WMD 10.1 mmHg, 95% CI 1.8–18.3). For the studies with BTM, Kaufman et al. [19] found a higher post-dialysis SBP with cool dialysis, while Schneditz et al. [23] found no difference and Beerenhout et al. did not directly compare the control and intervention arms (only start vs end comparisons were made). Pooled data showed a non-significant trend for higher post-dialysis SBP with BTM cool dialysis (WMD 8.7mmHg, −2.2–19.5). Overall effect for all of these studies showed a significantly higher post-dialysis SBP with cool dialysis (WMD 9.5 mmHg, 95% CI 3.0–16.1).
Delta SBP was reported in two studies examining a fixed temperature reduction [7,14] and two that examined BTM (one study isothermic dialysis, one study negative energy transfer) [16,23]. The pooled effect for fixed temperature reduction was a non-significant trend for a smaller drop in SBP with cool dialysis (WMD 5.5 mmHg, 95% CI −8.5–19.4), whereas for BTM the pooled results showed a significantly smaller fall in SBP with cooling (WMD 4.9 mmHg, 95% CI 1.5–8.5). The overall effect for all of these studies showed a significant benefit with cooling (WMD 5.0 mmHg, 95% CI 1.5–8.4).
Six of these studies examined patients who were stable on dialysis [9,14,20,22,24,25], and a further study reported separate results for stable and unstable patient subgroups [17]. Individual results from two of these studies reported no improvement in BP with dialysate cooling in stable patients [17,22], whereas the other five studies did report significant differences. However, of the studies that did report significant differences, Hegbrant et al. [20] used a dialysate temperature of 38.5°C in the control arm that is likely to have predisposed the control group to greater falls in BP; and Kishimoto et al. [9] reduced the room temperature in addition to cooling the dialysate in the intervention arm, and reported effects on BP after only 1 h of dialysis.
Symptoms
The reporting of intradialytic symptoms was generally poor, and those studies that did report thermal symptoms during dialysis did not uniformly rate their severity or precisely define their frequency [6,8,10,15–17]. Of the five studies that reported symptoms during fixed temperature reduction, two reported no symptoms in either the control or intervention arms (intervention dialysate temperature 35.5°C) [6,10]. The other three studies reported increased frequency of thermal symptoms during the intervention arm. Ayoub and Finlayson [17] (dialysate cooled to 35.0°C) did not comment regarding the severity but implied cool dialysis was well tolerated. Cruz et al. [15] reported that 13–19% of patients felt cool in the intervention arm with a dialysate temperature of 35.0°C vs 1–2% with standard dialysis, but only one patient reported severe, unpleasant symptoms. Dheenan and Henrich [8] reported that 70% felt colder during the intervention (dialysate temperature 35.0°C) and two (out of 10) patients had unpleasant symptoms of cold (shivering). The only report of symptoms with BTM was that of Maggiore et al. who employed isothermic dialysis; in this large study, patients felt cooler in 5% of treatments with isothermic dialysis, but there were no reports of unpleasant thermal symptoms. When results are pooled to examine for severe symptoms of cold, the overall effect is that symptoms occur 2.0 (95% CI, 0.4–3.6) times more commonly with temperature reduction. However, the study by Ayoub and Finlayson [17] implies that only mild symptoms occurred. If this study is excluded from the analysis, the pooled results become statistically non-significant, with only a trend towards an increased rate of symptoms, occurring 1.5 (95% CI, −0.2–3.2) times more frequently than during standard HD. These data are summarized in Figure 4.
Body temperature
Seven studies reported pre- and post-dialysis body temperature [7,17,18,20,22,23,25], and six reported delta body temperature [10,13,14,19,24,26]. Pre-dialysis body temperature was equal in all the studies.
Pooled results show that post dialysis body temperature was significantly lower with cool dialysate (WMD −0.8°C, 95% CI −0.1 to −0.7), and this effect was seen for both fixed temperature and BTM. van Der Sande et al. [26] confirmed that isothermic dialysis with BTM is accurate and did not produce a change in core temperature. This study was not included in the pooled analysis. Equally, delta body temperature was also significantly greater with cooling dialysate by all techniques (WMD −0.6°C, 95% CI −0.7 to −0.5), and this effect was also significant for both fixed reduction and BTM (negative energy transfer or programmed cooling).
Dialysis adequacy
Six studies reported dialysis adequacy as an outcome measure; five reported Kt/Vurea [13,15–17,19] and two reported URR [8,17]. None of these individual studies reported a difference in adequacy. For the pooled results, there were no differences between cool dialysis and control for either Kt/V or URR; this held true for fixed temperature reduction, BTM and overall results. The WMD for Kt/V was 0.04 (95% CI, −0.02–0.9) and for URR was 0.9 (95% CI, −5.3–7.3). Kt/V data are shown in Figure 5.
Of the papers that reported Kt/V, four reported equilibrated Kt/V (Kt/Ve) and only one reported single-pool Kt/V [15]. Of the studies reporting Kt/Ve, two presented a modelled value from blood tests immediately post dialysis and two presented Kt/Ve calculated from two-point blood sampling post dialysis (time = 0 and 30 min) [13,19]. Neither of the studies presenting two-point urea kinetic modelling found any differences in Kt/Ve or in urea rebound between standard and cool dialysis.
Systemic haemodynamics
Haemodynamics were measured by a variety of techniques and results presented in a variety of different units and formats, and therefore statistical analysis of these data was not possible. Six studies reported systemic haemodynamics with fixed temperature reduction [9–11,13,14,21], and three with BTM [19,26,27]. Seven of these studies reported a significant increase in vascular resistance during cool dialysis. Four studies used thoracic impedance to measure haemodynamics [9,13,19,27]. Jost et al. [11] derived vascular resistance by measuring calf blood flow, whereas van Der Sande et al. [10] reported forearm vascular resistance and skin blood flow [26]. Only two studies produced conflicting results and found a reduction in vascular resistance with cool dialysis [14,21]. Both these studies used the ultrasound dilution technique to derive haemodynamic data. Hoeben et al. [21] concluded that the effects of cooling the dialysate were mediated by a better preservation of central blood volume as opposed to effects on vascular resistance. Beerenhout et al. [25] were more circumspect, and commented on the potential weaknesses of the ultrasound dilution technique in the absence of invasive BP monitoring. Four studies reported the effects of cool dialysis on heart rate [9,13,16]. With fixed temperature reduction, Kishimoto et al. [9] found a lower heart rate with cool dialysis whilst Yu et al. [13] found no difference. Regarding the effect of BTM, Maggiore et al. [16] found a lower heart rate with isothermic dialysis, and with programmed cooling Beerenhout et al. [25] found a non-significant trend towards lower heart rate.
Other outcome measures
The study by Levy et al. [22] is the only one to measure ventricular contractility during cool and standard dialysis (fixed temperature reduction). They reported a significantly greater increase in the velocity of circumferential fibre shortening with cool dialysis. Four studies measured the effect of cooling the dialysate on plasma noradrenalin levels [9,11,20,22] and two reported the effect on nitric oxide (NO) [6,25]. Only one of the four studies could demonstrate a significantly greater plasma noradrenalin level with cool-temperature dialysis [11], and this difference only became apparent when patients stood up, with no difference observed in the post-dialysis level with patients lying. Jamil et al. [6] measured products of NO breakdown, and found a greater fall with cool-temperature dialysis. The authors concluded that standard dialysis results in greater NO production. Beerenhout et al. [25] measured NO synthetic capacity ex vivo using the stimulatory effect of plasma collected during standard dialysis and programmed cooling with BTM. The authors reported a significant increase in NO synthetic capacity during standard but not during cool dialysis, although this may reflect local activation in the dialyser that was ameliorated by the latter therapy.
Discussion
Summary
This review shows that reducing dialysate temperature is an effective intervention to reduce the rate of IDH. There was also a significant beneficial effect on BP, with a smaller fall in BP and higher post-dialysis BP (both SBP and MAP) with cool dialysis. These effects were apparent with empirical fixed reduction of dialysate temperature and BTM, although with the latter technique some of the BP effects did not reach statistical significance, possibly due to a smaller number of studies. We also observed that reducing dialysate temperature does not have any effect on dialysis adequacy.
Cool dialysis was also observed to reduce patients’ body temperature to a greater extent than standard dialysis. However, it was difficult to make any firm conclusions about the frequency of thermal symptoms due to the quality of the data. Overall, there was a trend to an increased frequency of cold symptoms with cool dialysis, but this was not a universal finding across all studies. The two studies that reported no symptoms during cool dialysis used a slightly higher dialysate temperature (35.5°C) than the studies in which symptoms did occur (35.0°C).
The beneficial effects of cool dialysate on BP appear to be due to higher peripheral resistance during cool dialysis. Although two studies reported no change or lower peripheral resistance with cool dialysate, these anomalous results may possibly reflect the measurement technique used (ultrasound dilution). We did not observe a significant effect of cool dialysis on plasma noradrenalin levels. Two studies did suggest a reduction in NO production during cool temperature dialysis, which may play a part in the haemodynamic effects, but these studies did not prove a causal relationship between NO and dialysis stability.
Strengths of this review
This is the first systematic review examining the effects of dialysate temperature reduction on stability during dialysis. This has clinical relevance because cool dialysis (with a fixed reduction in temperature) can be delivered by all dialysis monitors at no additional cost. The review offers a complete overview as we have performed an extensive literature search, including unpublished data and that presented in abstract form. In addition, the review is up-to-date and only examines dialysis techniques that are in current practice.
Limitations of review
As with many studies in the area of dialysis, the majority of the included studies had small patient numbers. In addition, there was some heterogeneity in study methodology and intervention. In particular, there were some variations in the exact temperature settings in control and intervention arms. As such, it is not possible to determine the optimal temperature setting to reduce IDH without increasing the unpleasant thermal symptoms. Furthermore, the reporting of severity and frequency of cold symptoms across the studies was inconsistent. The effects of fixed reduction in dialysate temperature on thermal balance and, therefore, clinical effects may vary between patients as they are affected by individual core temperature, blood flow and access recirculation. These factors are less with BTM that takes these into account. However, these data were generally reported poorly. Finally, all of the studies were short-term (the longest lasting 9 weeks), and there are no studies that report the effect of cool dialysis on long-term patient outcomes.
Conclusions
Implications for practice
Reducing the temperature of the dialysate is an effective intervention to reduce the frequency of IDH. Cool dialysis does not adversely affect dialysis adequacy. This applies to fixed reduction of dialysate temperature and to that employing BTM. It remains unclear as to what extent cool-temperature dialysis causes intolerable cold symptoms during dialysis.
Implications for research
New studies that examine the effect of dialysate temperature reduction on IDH frequency would be redundant. However, more research is required to define the precise temperature at which maximum benefit is achieved without increase in symptoms. It is also necessary to examine the effect of cool dialysis on long-term patient outcomes, as improving dialysis stability and reducing IDH could theoretically impact this. Finally, a comparison between empirical reduction of dialysate temperature and isothermic dialysis with BTM is required to see if the latter treatment (which is more complex and less widely available) confers benefit in terms of fewer symptoms of cold whilst still providing a reduction in IDH. For future studies, a scoring system to rate the severity and frequency of cold symptoms should be developed.
Appendix—data collection form
Study ID
Methods
Randomized? A adequate B unclear C inadequate D not used
Blinded? Participant Y/N/U provider Y/N/U outcome assessor Y/N/U data analyst Y/N/U
Study design
Duration
Intention to treat analysis Yes Yes (but not reported) No Unclear
(After randomization, pts should be included even if they don’t receive the intervention)
Drop-outs (%)
Confounding factors
Participants
Number
Age
Sex
HD details (vintage, stable or unstable etc)
Co-morbidity
Exclusion/inclusion criteria
Interventions (state temperature of specific ints, duration)
Outcomes (state units, plus n, mean, SD, P-value)
IDH
Symptoms
BP
Haemodynamics
Kt/V
Body temperature
(other biochem)
Hormones/catechol/NO
Other points
We gratefully acknowledge the help of Caroline White, Senior Librarian and Apostolos Fakis, Medical Statistician.
Conflict of interest statement. None declared.
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Author notes
1Department of Renal Medicine, Derby City Hospital, Derby and 2Centre for Integrated Systems Biology and Medicine, University of Nottingham, Nottingham, UK
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