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Please use this identifier to cite or link to this item: http://hdl.handle.net/11055/566
Title: Restrictive versus liberal fluid therapy for major abdominal surgery
Authors: Myles, PS
Bellomo, R
Corcoran, T
Forbes, A
Peyton, P
Story, D
Christophi, C
Leslie, K
McGuinness, S
Parke, R
Serpell, J
Chan, MTV
Painter, T
McCluskey, S
Minto, G
Wallace, S
ANZCA Clinical Trials Network
NZ Intensive Care Society Clinical Trials Group
ANZCA/FPM Author: ANZCA Clinical Trials Network
Chan, MTV
Leslie, K
McGuinness, S
Myles, PS
Painter, TW
Peyton, PJ
Story, D
Keywords: major surgery
perfusion
restrictive fluid regimen
RELIEF
Citation: 2018; doi:10.1056/NEJMoa1801601
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.)
URI: http://hdl.handle.net/11055/566
DOI: 10.1056/NEJMoa1801601
PubMed URL: https://www.nejm.org/doi/full/10.1056/NEJMoa1801601
ISSN: 0028-4793
Study Name: NCT01424150
Journal Title: The New England Journal of Medicine
Type: Journal Article
Affiliates: Australian and New Zealand College of Anaesthetists
Alfred Hospital
Monash University
University of Melbourne
Austin Hospital, Heidelberg
Royal Perth Hospital
University of Western Australia, Perth
Royal Melbourne Hospital
Royal Adelaide Hospital
Discipline of Acute Care Medicine, University of Adelaide
Auckland City Hospital
Medical Research Institute of New Zealand
Chinese University of Hong Kong
University Health Network, Toronto
Derriford Hospital, Plymouth, United Kingdom
Study/Trial: Random Allocation
Appears in Collections:Scholarly and Clinical

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