6/29/23, 1:10 AM RELIEF Pathway Feedback Search Clinical Topics Home Studies RELIEF RELIEF Trial question What is the role of restrictive fluid regimen among patients at increased risk for complications during major abdominal surgery? Study design Multi-center Open label RCT Population Characteristics of study participants 48.0% female N = 3000 52.0% male 3000 patients (1429 female, 1554 male) Inclusion criteria: patients who had an increased risk of complications while undergoing major abdominal surgery Key exclusion criteria: undergoing urgent or time-critical surgery, liver resection, or less extensive surgery, or end-stage kidney failure requiring dialysis Interventions N=1490 a restrictive fluid regimen (a median intravenous-fluid intake of 3.7 L) N=1493 a liberal fluid regimen (a median intravenous-fluid intake of 6.1 L) Primary outcome Disability-free survival at 1 year 82.3 % 82.3 81.9 61.7 % 41.1 % 20.6 % https://web.pathway.md/studies/recqW2vE0J1HecZzC 1/2 6/29/23, 1:10 AM RELIEF Pathway No significant difference 0.0 % A restrictive fluid regimen A liberal fluid regimen No significant difference in disability-free survival at 1 year (81.9% vs. 82.3%; HR 1.05, 95% CI 0.88 to 1.24) Secondary outcomes No significant difference in septic outcome or death (21.8% vs. 19.8%; HR 1.1, 95% CI 0.96 to 1.27) Significant increase in surgical site infection (16.5% vs. 13.6%; HR 1.22, 95% CI 1.03 to 1.45) No significant difference in sepsis (10.6% vs. 8.7%; HR 1.22, 95% CI 0.98 to 1.52) Safety outcomes No significant differences in pneumonia, pulmonary edema, death. Significant differences in AKI (8.6% vs. 5.0%), RRT (0.9% vs. 0.3%). Conclusion In patients who had an increased risk of complications while undergoing major abdominal surgery, a restrictive fluid regimen was not superior to a liberal fluid regimen with respect to a disability-free survival at 1 year. Reference Paul S Myles, Rinaldo Bellomo, Tomas Corcoran et al. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. Open reference URL https://web.pathway.md/studies/recqW2vE0J1HecZzC 2/2