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Title: Trial of early, goal-directed resuscitation for septic shock.
Authors: Mouncey, P. R.
Osborn, T. M.
Power, G. S.
Harrison, D. A.
Sadique, M. Z.
Grieve, R. D.
Jahan, R.
Harvey, S. E.
Bell, D.
Bion, J. F.
Coats, Timothy J.
Singer, M.
Young, J. D.
Rowan, K. M.
ProMISe Trial Investigators
First Published: 17-Mar-2015
Publisher: Massachusetts Medical Society
Citation: New England Journal of Medicine, 2015, 372 (14), pp. 1301-1311
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.
DOI Link: 10.1056/NEJMoa1500896
ISSN: 0028-4793
eISSN: 1533-4406
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: Archived with reference to SHERPA/RoMEO and publisher website. From New England Journal of Medicine, Paul R. Mouncey, M.Sc., Tiffany M. Osborn, M.D., G. Sarah Power, M.Sc., David A. Harrison, Ph.D., M. Zia Sadique, Ph.D., Richard D. Grieve, Ph.D., Rahi Jahan, B.A., Sheila E. Harvey, Ph.D., Derek Bell, M.D., Julian F. Bion, M.D., Timothy J. Coats, M.D., Mervyn Singer, M.D., J. Duncan Young, D.M., and Kathryn M. Rowan, Ph.D. for the ProMISe Trial Investigators, Trial of Early, Goal-Directed Resuscitation for Septic Shock, 372 (14), pp. 1301-1311. Copyright ©2015 Massachusetts Medical Society. Reprinted with permission.
Appears in Collections:Published Articles, Dept. of Cardiovascular Sciences

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