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Title: Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial.
Authors: Myles, Paul;Bellomo, Rinaldo;Corcoran, Tomas;Forbes, Andrew;Wallace, Sophie;Peyton, Philip J;Christophi, Christopher;Story, David;Leslie, Kate;Serpell, Jonathan;McGuinness, Shay;Parke, Rachel
Affiliation: Royal Melbourne Hospital, Melbourne, Victoria, Australia
Alfred Hospital, Melbourne, Victoria, Australia
University of Western Australia, Melbourne, Victoria, Australia
Monash University, Melbourne, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
The University of Melbourne, Melbourne, Victoria, Australia
Auckland City Hospital, Auckland, New Zealand
Issue Date: 10-Mar-2017
EDate: 2017-03-10
Citation: BMJ open 2017; 7(3): e015358
Abstract: 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. 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. 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. identifier NCT01424150.
DOI: 10.1136/bmjopen-2016-015358
ORCID: 0000-0002-1650-8939
PubMed URL: 28259855
Type: Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Appears in Collections:Journal articles

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