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May - 2018

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Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery

P Myles, R Bellomo, T. Corcoran, etal ANZCA CTN and the ANZICS CTG New Engl J Med, 2018, Online first 10th May

Comment

Does a restrictive or liberal perioperative IV fluid regimens lead to better outcomes for high-risk patients undergoing major abdominal surgery?

This pragmatic, international trial, RCT, randomised 3000 patients who had an increased risk of complications while undergoing major abdominal surgery to receive;

  • Restrictive intravenous-fluid regimen during and up to 24 hours after surgery, and they received median intravenous-fluid intake of 3.7 liters (IQR, 2.9 to 4.9)
  • Liberal intravenous-fluid regimen during and up to 24 hours after surgery, and they received median intravenous-fluid intake 6.1 liters (IQR, 5.0 to 7.4)(P<0.001)

They report

  • Primary outcome disability-free survival at 1 year, 81.9% restrictive vs 82.3% liberal (HR, 1.05; 95% CI, 0.88 to 1.24; P=0.61). Disability was defined as a persistent impairment in health status (lasting ≥6 months), as measured by a score of at least 24 points on the WHODAS questionnaire, which reflects a disability level of at least 25% (the threshold point between “disabled” and “not disabled”).23,27 The WHODAS questionnaire was completed by the patient or by a proxy (a spouse or caregiver) if the patient was not able to complete it.
  • Acute kidney injury 8.6% restrictive vs  5.0% liberal (P<0.001)
  • Septic complications or death  21.8% restrictive vs 19.8% liberal (P=0.19)
  • Surgical-site infection (16.5% R vs. 13.6% L, P=0.02) and renal-replacement therapy (0.9% Rvs. 0.3% L, P=0.048), but between-group difference not significant after adjustment for multiple testing
  • No difference in ICU LOS or MV duration

Overall restrictive fluid regimen was not associated with a higher rate of disability-free survival than a liberal fluid regimen, in patients at increased risk for complications during major abdominal surgery. Restrictive fluid was associated with a higher rate of acute kidney injury. 


 

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.

May


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