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N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.

Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery.

Author information

1
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.).

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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 .).

PMID:
29742967
DOI:
10.1056/NEJMoa1801601
[Indexed for MEDLINE]
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