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BMJ Open. 2017 Mar 3;7(3):e015358. doi: 10.1136/bmjopen-2016-015358.

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

Author information

1
Alfred Hospital, Melbourne, Victoria, Australia.
2
Monash University, Melbourne, Victoria, Australia.
3
Austin Hospital, Melbourne, Victoria, Australia.
4
The University of Melbourne, Melbourne, Victoria, Australia.
5
University of Western Australia, Melbourne, Victoria, Australia.
6
Royal Melbourne Hospital, Melbourne, Victoria, Australia.
7
Auckland City Hospital, Auckland, New Zealand.

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

PMID:
28259855
PMCID:
PMC5353290
DOI:
10.1136/bmjopen-2016-015358
[Indexed for MEDLINE]
Free PMC Article

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