From Alfred Hospital (P.S.M., J.S., S.W.), Monash University (P.S.M., R.B., T.C., A.F., K.L., J.S., S.W.), and the University of Melbourne (R.B., P.P., D.S., C.C., K.L.), Melbourne, VIC, Austin Hospital, Heidelberg, VIC (R.B., P.P., D.S., C.C.), Royal Perth Hospital and the University of Western Australia, Perth (T.C.), Royal Melbourne Hospital, Parkville, VIC (K.L.), and Royal Adelaide Hospital and Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA (T.P.) - all in Australia; Auckland City Hospital, Auckland, and the Medical Research Institute of New Zealand, Wellington - both in New Zealand (S. McGuinness, R.P.); the Chinese University of Hong Kong, Hong Kong (M.T.V.C.); University Health Network, Toronto (S. McCluskey); and Derriford Hospital, Plymouth, United Kingdom (G.M.).
N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.
Guidelines to promote the early recovery of patients undergoing major surgery recommend a restrictive intravenous-fluid strategy for abdominal surgery. However, the supporting evidence is limited, and there is concern about impaired organ perfusion.
In a pragmatic, international trial, we randomly assigned 3000 patients who had an increased risk of complications while undergoing major abdominal surgery to receive a restrictive or liberal intravenous-fluid regimen during and up to 24 hours after surgery. The primary outcome was disability-free survival at 1 year. Key secondary outcomes were acute kidney injury at 30 days, renal-replacement therapy at 90 days, and a composite of septic complications, surgical-site infection, or death.
During and up to 24 hours after surgery, 1490 patients in the restrictive fluid group had a median intravenous-fluid intake of 3.7 liters (interquartile range, 2.9 to 4.9), as compared with 6.1 liters (interquartile range, 5.0 to 7.4) in 1493 patients in the liberal fluid group (P<0.001). The rate of disability-free survival at 1 year was 81.9% in the restrictive fluid group and 82.3% in the liberal fluid group (hazard ratio for death or disability, 1.05; 95% confidence interval, 0.88 to 1.24; P=0.61). The rate of acute kidney injury was 8.6% in the restrictive fluid group and 5.0% in the liberal fluid group (P<0.001). The rate of septic complications or death was 21.8% in the restrictive fluid group and 19.8% in the liberal fluid group (P=0.19); rates of surgical-site infection (16.5% vs. 13.6%, P=0.02) and renal-replacement therapy (0.9% vs. 0.3%, P=0.048) were higher in the restrictive fluid group, but the between-group difference was not significant after adjustment for multiple testing.
Among patients at increased risk for complications during major abdominal surgery, a restrictive fluid regimen was not associated with a higher rate of disability-free survival than a liberal fluid regimen and was associated with a higher rate of acute kidney injury. (Funded by the Australian National Health and Medical Research Council and others; RELIEF ClinicalTrials.gov number, NCT01424150 .).
促进大手术患者早期康复的指南建议对腹部手术采用限制静脉补液策略。然而，支持这种策略的证据有限，并且人们担心会损害器官灌注。
在一项实用的国际试验中，我们将 3000 名在接受大型腹部手术后有并发症风险增加的患者随机分配，在手术期间和术后 24 小时内接受限制或宽松的静脉补液方案。主要结局是 1 年时无残疾生存。主要次要结局是术后 30 天急性肾损伤、术后 90 天肾脏替代治疗以及脓毒症并发症、手术部位感染或死亡的复合结局。
在手术期间和术后 24 小时内，限制补液组的 1490 名患者的中位静脉补液量为 3.7 升（四分位距，2.9 至 4.9），而宽松补液组的 1493 名患者为 6.1 升（四分位距，5.0 至 7.4）（P<0.001）。限制补液组 1 年时无残疾生存率为 81.9%，宽松补液组为 82.3%（死亡或残疾的风险比，1.05；95%置信区间，0.88 至 1.24；P=0.61）。限制补液组急性肾损伤发生率为 8.6%，宽松补液组为 5.0%（P<0.001）。限制补液组感染性并发症或死亡发生率为 21.8%，宽松补液组为 19.8%（P=0.19）；手术部位感染率（16.5% vs. 13.6%，P=0.02）和肾脏替代治疗率（0.9% vs. 0.3%，P=0.048）在限制补液组较高，但经多次检验校正后差异无统计学意义。
在接受大型腹部手术有并发症风险增加的患者中，与宽松液体方案相比，限制液体方案并未导致更高的无残疾生存率，反而与更高的急性肾损伤发生率相关。（由澳大利亚国家卫生和医学研究理事会等资助；RELIEF ClinicalTrials.gov 编号，NCT01424150）。
