Restrictive versus liberal fluid therapy for major abdominal surgery

P. S. Myles, R. Bellomo, T. Corcoran, A. Forbes, P. Peyton, D. Story, C. Christophi, Kate Leslie, S. McGuinness, R. Parke, J. Serpell, M. T.V. Chan, T. Painter, S. McCluskey, G. Minto, Sophia Wallace

Research output: Contribution to journalArticleResearchpeer-review

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.).

Original languageEnglish
Pages (from-to)2263-2274
Number of pages12
JournalNew England Journal of Medicine
Volume378
Issue number24
DOIs
Publication statusPublished - 14 Jun 2018

Cite this

Myles, P. S. ; Bellomo, R. ; Corcoran, T. ; Forbes, A. ; Peyton, P. ; Story, D. ; Christophi, C. ; Leslie, Kate ; McGuinness, S. ; Parke, R. ; Serpell, J. ; Chan, M. T.V. ; Painter, T. ; McCluskey, S. ; Minto, G. ; Wallace, Sophia. / Restrictive versus liberal fluid therapy for major abdominal surgery. In: New England Journal of Medicine. 2018 ; Vol. 378, No. 24. pp. 2263-2274.
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title = "Restrictive versus liberal fluid therapy for major abdominal surgery",
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.).",
author = "Myles, {P. S.} and R. Bellomo and T. Corcoran and A. Forbes and P. Peyton and D. Story and C. Christophi and Kate Leslie and S. McGuinness and R. Parke and J. Serpell and Chan, {M. T.V.} and T. Painter and S. McCluskey and G. Minto and Sophia Wallace",
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Restrictive versus liberal fluid therapy for major abdominal surgery. / Myles, P. S.; Bellomo, R.; Corcoran, T.; Forbes, A.; Peyton, P.; Story, D.; Christophi, C.; Leslie, Kate; McGuinness, S.; Parke, R.; Serpell, J.; Chan, M. T.V.; Painter, T.; McCluskey, S.; Minto, G.; Wallace, Sophia.

In: New England Journal of Medicine, Vol. 378, No. 24, 14.06.2018, p. 2263-2274.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Restrictive versus liberal fluid therapy for major abdominal surgery

AU - Myles, P. S.

AU - Bellomo, R.

AU - Corcoran, T.

AU - Forbes, A.

AU - Peyton, P.

AU - Story, D.

AU - Christophi, C.

AU - Leslie, Kate

AU - McGuinness, S.

AU - Parke, R.

AU - Serpell, J.

AU - Chan, M. T.V.

AU - Painter, T.

AU - McCluskey, S.

AU - Minto, G.

AU - Wallace, Sophia

PY - 2018/6/14

Y1 - 2018/6/14

N2 - 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.).

AB - 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.).

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U2 - 10.1056/NEJMoa1801601

DO - 10.1056/NEJMoa1801601

M3 - Article

VL - 378

SP - 2263

EP - 2274

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 24

ER -