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REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study

NCT01424150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-01-20

Study results available
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Summary

The optimal fluid regimen, haemodynamic (or other) targets and fluid choice (colloid or crystalloid) for patients undergoing major surgery are based on rationales that are not supported by strong evidence. Practices vary substantially, guidelines are vague, small trials and meta-analyses are contradictory. The strongest and most consistent evidence, and biological plausibility because of tissue edema, supports a restrictive fluid strategy. But other evidence supports goal-directed therapy, requiring additional IV fluid. There is no good evidence that use and choice of colloids improves outcome. RELIEF will study the effects of fluid restriction, and the possible effect-modification of goal-directed therapy and colloids. The first will be randomly assigned; the latter will be measured covariates dictated by local practices and beliefs.

Study Hypotheses A restrictive fluid regimen for adults undergoing major abdominal surgery leads to reduced complications and improved disability-free survival when compared with a liberal fluid regimen.

Secondary hypothesis: The effects of fluid restriction are similar whether or not goal-directed therapy is used (assessed as a statistical test of interaction). A restrictive fluid regimen will reduce a composite of 30-day septic complications and mortality.

Conditions

  • Abdominal Surgery

Interventions

OTHER

Liberal fluid therapy

Liberal protocol group is designed to provide approximately 6.0L per day.

OTHER

Restrictive fluid therapy

Restrictive protocol group is designed to provide less than 2.0 L water and 120 mmol sodium per day.

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Paul S Myles, MB.BS, MPH, MD, FANZCA · Alfred Hospital, Monash University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-09-30
Completion
2017-10-22

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424150 on ClinicalTrials.gov