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Anaesthesia
Protocol
Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial
  1. Paul Myles1,2,
  2. Rinaldo Bellomo2,3,4,
  3. Tomas Corcoran5,
  4. Andrew Forbes2,
  5. Sophie Wallace1,2,
  6. Philip Peyton3,
  7. Chris Christophi3,4,
  8. David Story4,
  9. Kate Leslie2,4,6,
  10. Jonathan Serpell1,2,
  11. Shay McGuinness7,
  12. Rachel Parke7
  13. on behalf of the Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group
  1. 1Alfred Hospital, Melbourne, Victoria, Australia
  2. 2Monash University, Melbourne, Victoria, Australia
  3. 3Austin Hospital, Melbourne, Victoria, Australia
  4. 4The University of Melbourne, Melbourne, Victoria, Australia
  5. 5University of Western Australia, Melbourne, Victoria, Australia
  6. 6Royal Melbourne Hospital, Melbourne, Victoria, Australia
  7. 7Auckland City Hospital, Auckland, New Zealand
  1. Correspondence to Professor Paul S Myles; p.myles{at}alfred.org.au

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.

  • ANAESTHETICS
  • INTENSIVE & CRITICAL CARE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-015358

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    Footnotes

    • Collaborators The RELIEF trial investigators.

    • Contributors PM, TC, AF, PP, DS, KL and RB contributed to the conception and design of the study. PM, SW, AF, TC, PP, DS, KL, SM, RP and RB contributed to the acquisition, analysis and interpretation of the data. PM wrote the first draft of the protocol. PM, RB, TC, AF, SW, PP, CC, DS, KL, JS, SM and RP revised the protocol critically for important intellectual content. PM and RB are the guarantors. All authors have read and approved the final version of the manuscript to be published.

    • Funding This work was supported by the Australian NHMRC, the New Zealand Health Research Council, the Australian and New Zealand College of Anaesthetists and Monash University (Melbourne, Australia).

    • Disclaimer The sponsor and funding sources had no role in the design and conduct of the trial; collection, management, analysis and interpretation of the data; preparation, review or approval of this protocol paper and decision to submit this protocol manuscript for publication.

    • 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.

    • Patient consent Obtained.

    • Ethics approval Ethics committee approvals were obtained from each of the responsible bodies for all trial sites: Australia: Alfred Hospital Ethics Committee, Human Research and Ethics Committee Epworth Healthcare, Western Sydney Local Health District Human Research Ethics Committee, Queensland Metro South Human Research Ethics Committee, Human Research Ethics Committee (Tasmania) Network, Central Adelaide Local Health Network (South Australia), Human Research Ethics Committee (Medical Sciences), Macquarie University, Government of Western Australia, Department of Health, South Metropolitan Area Health Service (Queensland); UK: Health Research Authority NRES Committee South West Exeter; Hong Kong: Joint Chinese University of Hong Kong—New Territories East Cluster, Clinical Research Ethics Committee; New Zealand: Health and Disability Ethics Committees; Italy: Ospendale San Raffaele; Canada: Queens University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (Kingston), Research Ethics Board (Toronto), University Health Network, SDR Research Ethics Board (McGill University); USA: Cleveland Clinic Foundation Institutional Review Board, Institutional Review Board Weill Cornell Medical College, Institutional Review Board Wake Forest University Health Science.

    • Provenance and peer review Not commissioned; externally peer reviewed.