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Randomized Controlled Trial
. 2015 Apr 2;372(14):1301-11.
doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17.

Trial of early, goal-directed resuscitation for septic shock

Paul R Mouncey  1 , Tiffany M Osborn, G Sarah Power, David A Harrison, M Zia Sadique, Richard D Grieve, Rahi Jahan, Sheila E Harvey, Derek Bell, Julian F Bion, Timothy J Coats, Mervyn Singer, J Duncan Young, Kathryn M Rowan; ProMISe Trial Investigators
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Trial of early, goal-directed resuscitation for septic shock

Paul R Mouncey et al. N Engl J Med. .
Free article

Abstract

Background: Early, goal-directed therapy (EGDT) is recommended in international guidelines for the resuscitation of patients presenting with early septic shock. However, adoption has been limited, and uncertainty about its effectiveness remains.

Methods: We conducted a pragmatic randomized trial with an integrated cost-effectiveness analysis in 56 hospitals in England. Patients were randomly assigned to receive either EGDT (a 6-hour resuscitation protocol) or usual care. The primary clinical outcome was all-cause mortality at 90 days.

Results: We enrolled 1260 patients, with 630 assigned to EGDT and 630 to usual care. By 90 days, 184 of 623 patients (29.5%) in the EGDT group and 181 of 620 patients (29.2%) in the usual-care group had died (relative risk in the EGDT group, 1.01; 95% confidence interval [CI], 0.85 to 1.20; P=0.90), for an absolute risk reduction in the EGDT group of -0.3 percentage points (95% CI, -5.4 to 4.7). Increased treatment intensity in the EGDT group was indicated by increased use of intravenous fluids, vasoactive drugs, and red-cell transfusions and reflected by significantly worse organ-failure scores, more days receiving advanced cardiovascular support, and longer stays in the intensive care unit. There were no significant differences in any other secondary outcomes, including health-related quality of life, or in rates of serious adverse events. On average, EGDT increased costs, and the probability that it was cost-effective was below 20%.

Conclusions: In patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation, hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme; ProMISe Current Controlled Trials number, ISRCTN36307479.).

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