Trial of Early, Goal-Directed Resuscitation for Septic Shock

医学 早期目标导向治疗 复苏 感染性休克 随机对照试验 相对风险 重症监护室 休克(循环) 置信区间 重症监护医学 不利影响 急诊医学 败血症 内科学 严重败血症
作者
Paul R Mouncey,Tiffany M. Osborn,G Sarah Power,David A Harrison,Zia Sadique,Richard Grieve,Rahi Jahan,Sheila Harvey,Derek Bell,Julian Bion,Timothy J Coats,Mervyn Singer,John Young,Kathy Rowan,Abstr Act
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:372 (14): 1301-1311 被引量:1277
标识
DOI:10.1056/nejmoa1500896
摘要

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.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.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%.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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