Chest
Volume 132, Issue 2, August 2007, Pages 425-432
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Original Research
Critical Care Medicine
Prospective External Validation of the Clinical Effectiveness of an Emergency Department-Based Early Goal-Directed Therapy Protocol for Severe Sepsis and Septic Shock

https://doi.org/10.1378/chest.07-0234Get rights and content

Objective

To determine the clinical effectiveness of implementing early goal-directed therapy (EGDT) as a routine protocol in the emergency department (ED).

Methods

Prospective interventional study conducted over 2 years at an urban ED. Inclusion criteria included suspected infection, criteria for systemic inflammation, and either systolic BP < 90 mm Hg after a fluid bolus or lactate concentration ≥ 4 mol/L. Exclusion criteria were age < 18 years, contraindication to a chest central venous catheter, and need for immediate surgery. We prospectively recorded preintervention clinical and mortality data on consecutive, eligible patients for 1 year when treatment was at the discretion of board-certified emergency physicians. We then implemented an EGDT protocol (the intervention) and recorded clinical data and mortality rates for 1 year. Prior to the first year, we defined a 33% relative reduction in mortality (relative mortality reduction that was found in the original EGDT trial) to indicate clinical effectiveness of the intervention.

Results

We enrolled 79 patients in the preintervention year and 77 patients in the postintervention year. Compared with the preintervention year, patients in the postintervention year received significantly greater crystalloid volume (2.54 L vs 4.66 L, p < 0.001) and frequency of vasopressor infusion (34% vs 69%, p < 0.001) during the initial resuscitation. In-hospital mortality was 21 of 79 patients (27%) before intervention, compared with 14 of 77 patients (18%) after intervention (absolute difference, − 9%; 95% confidence interval, + 5 to − 21%).

Conclusions

Implementation of EGDT in our ED was associated with a 9% absolute (33% relative) mortality reduction. Our data provide external validation of the clinical effectiveness of EGDT to treat sepsis and septic shock in the ED.

Section snippets

Study Design and Setting

We performed a prospective before and after study of the clinical effectiveness, defined as the change in mortality caused by the intervention of an EGDT protocol for the early treatment of severe sepsis and septic shock in the ED. The protocol was implemented as a clinical pathway in the time frame diagrammed in Figure 1 . This study was reviewed and approved by the institutional review board and privacy board of Carolinas Healthcare System.

All patients were enrolled in the ED at Carolinas

Results

We enrolled 157 patients: 79 in the before phase (August 1, 2004, to September 30, 2005) and 77 in the after phase (November 1, 2005, to October 31, 2006). In all 77 postintervention patients, ED physicians and staff identified the patients, initiated the goal-directed resuscitation protocol, placed the central venous catheter, administered antimicrobial medications, and followed the protocol until a bed in the ICU was available for patient transfer. Table 1 shows the demographics,

Discussion

In this study, we document the clinical effectiveness of implementing an EGDT algorithm for the management of severe sepsis and septic shock in the ED. We found a 9% absolute and 33% relative mortality reduction, suggesting a number needed to treat (1/absolute mortality reduction) of approximately 11 persons. Furthermore, this mortality benefit was found among a group of patients with at least equal hemodynamic instability based on inspection of the systolic BP and sequential organ failure

Conclusion

In this investigation we demonstrate the clinical effectiveness, quantified by a 9% absolute and 33% relative mortality reduction, of implementing EGDT in ED patients with severe sepsis and septic shock. Our data suggest a number needed to treat of approximately 11 persons.

ACKNOWLEDGMENT

We wish to thank all of the emergency medicine and critical care physicians and nurses, whose tireless efforts and dedication to the care of sepsis patients at our institution is impeccable. Additionally, we would like to thank the following members of our institutional sepsis task force for their efforts in operationalizing this protocol: Nancy Gritter, MD; Daniel Howard, MD; Toan Huynh, MD; Mike Johnson, MD; Eddie Leonhardt, RN; Lewis McCurdy, MD; Stephen Moore, MD; Richard Rissmiller, Jr,

References (19)

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The author's institution received a $3,000 educational grant from Edwards Lifesciences for continuing nursing and physician education.

Dr Jones is supported by grant K23GM076652–01A1 from the National Institute of General Medical Sciences/National Institutes of Health.

None of the authors have conflicts of interest to report.

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