Prospective external validation of the clinical effectiveness of an emergency department-based early goal-directed therapy protocol for severe sepsis and septic shock

Abstract

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.

Figure 1

Timeline of data collection and protocol implementation.

Figure 2

Goal-directed resuscitation algorithm. SIRS = systemic inflammatory response syndrome; MAP = mean arterial pressure; SBP = systolic BP; IJ = internal jugular; SC = subclavian; HCT = hematocrit; HR = heart rate; NS = normal saline solution; DNR = do not resuscitate.

Figure 3

Kaplan-Meier survival curve comparing survival of patients in the pre-EGDT intervention (before phase) and post-EGDT intervention (after group). This curve represents truncated data so that absolute survival is not observed on the plot but rather the survival in relation to hospital LOS. The time points represent the number of patients that remain in the hospital and are at risk of death.