Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial

Paul Myles, Rinaldo Bellomo, Tomas Corcoran, Andrew Forbes, Sophie Wallace, Philip Peyton, Chris Christophi, David Story, Kate Leslie, Jonathan Serpell, Shay McGuinness, Rachel Parke, Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group, Paul Myles, Rinaldo Bellomo, Tomas Corcoran, Andrew Forbes, Sophie Wallace, Philip Peyton, Chris Christophi, David Story, Kate Leslie, Jonathan Serpell, Shay McGuinness, Rachel Parke, Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group

Abstract

Introduction: The optimal intravenous fluid regimen for patients undergoing major abdominal surgery is unclear. However, results from many small studies suggest a restrictive regimen may lead to better outcomes. A large, definitive clinical trial evaluating perioperative fluid replacement in major abdominal surgery, therefore, is required.

Methods/analysis: We designed a pragmatic, multicentre, randomised, controlled trial (the RELIEF trial). A total of 3000 patients were enrolled in this study and randomly allocated to a restrictive or liberal fluid regimen in a 1:1 ratio, stratified by centre and planned critical care admission. The expected fluid volumes in the first 24 hour from the start of surgery in restrictive and liberal groups were ≤3.0 L and ≥5.4 L, respectively. Patient enrolment is complete, and follow-up for the primary end point is ongoing. The primary outcome is disability-free survival at 1 year after surgery, with disability defined as a persistent (at least 6 months) reduction in functional status using the 12-item version of the World Health Organisation Disability Assessment Schedule.

Ethics/dissemination: The RELIEF trial has been approved by the responsible ethics committees of all participating sites. Participant recruitment began in March 2013 and was completed in August 2016, and 1-year follow-up will conclude in August 2017. Publication of the results of the RELIEF trial is anticipated in early 2018.

Trial registration number: ClinicalTrials.gov identifier NCT01424150.

Keywords: ANAESTHETICS; INTENSIVE & CRITICAL CARE.

Conflict of interest statement

Competing interests: RB has received grants and consultancy fees from two international fluid manufacturers (Baxter and BBraun). None of the other authors have any conflicts of interest.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Fluid administration during surgery and up to 24 hours postoperatively in the restrictive and liberal groups.

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