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, Australian and New Zealand Intensive Care Society Clinical Trials Group

Research output: Contribution to journalArticleResearchpeer-review

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 24â €..hour from the start of surgery in restrictive and liberal groups were ≤3.0â €..L and ≥5.4â €..L, respectively. Patient enrolment is complete, and follow-up for the primary end point is ongoing. The primary outcome is disability-free survival at 1â €..year after surgery, with disability defined as a persistent (at least 6â €..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.

Original languageEnglish
Article numbere015358
Number of pages9
JournalBMJ Open
Volume7
Issue number3
DOIs
Publication statusPublished - 1 Mar 2017

Cite this

Myles, Paul ; Bellomo, Rinaldo ; Corcoran, Tomas ; Forbes, Andrew ; Wallace, Sophie ; Peyton, Philip ; Christophi, Chris ; Story, David ; Leslie, Kate ; Serpell, Jonathan ; McGuinness, Shay ; Parke, Rachel ; Australian and New Zealand College of Anaesthetists Clinical Trials Network ; Australian and New Zealand Intensive Care Society Clinical Trials Group. / Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF) : Rationale and design for a multicentre randomised trial. In: BMJ Open. 2017 ; Vol. 7, No. 3.
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title = "Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): Rationale and design for a multicentre randomised trial",
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{\^a} €..hour from the start of surgery in restrictive and liberal groups were ≤3.0{\^a} €..L and ≥5.4{\^a} €..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{\^a} €..year after surgery, with disability defined as a persistent (at least 6{\^a} €..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.",
author = "Paul Myles and Rinaldo Bellomo and Tomas Corcoran and Andrew Forbes and Sophie Wallace and Philip Peyton and Chris Christophi and David Story and Kate Leslie and Jonathan Serpell and Shay McGuinness and Rachel Parke and {Australian and New Zealand College of Anaesthetists Clinical Trials Network} and {Australian and New Zealand Intensive Care Society Clinical Trials Group}",
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Myles, P, Bellomo, R, Corcoran, T, Forbes, A, Wallace, S, Peyton, P, Christophi, C, Story, D, Leslie, K, Serpell, J, McGuinness, S, Parke, R, Australian and New Zealand College of Anaesthetists Clinical Trials Network & Australian and New Zealand Intensive Care Society Clinical Trials Group 2017, 'Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): Rationale and design for a multicentre randomised trial', BMJ Open, vol. 7, no. 3, e015358. https://doi.org/10.1136/bmjopen-2016-015358

Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF) : Rationale and design for a multicentre randomised trial. / Myles, Paul; Bellomo, Rinaldo; Corcoran, Tomas; Forbes, Andrew; Wallace, Sophie; Peyton, Philip; Christophi, Chris; Story, David; Leslie, Kate; Serpell, Jonathan; McGuinness, Shay; Parke, Rachel; Australian and New Zealand College of Anaesthetists Clinical Trials Network; Australian and New Zealand Intensive Care Society Clinical Trials Group.

In: BMJ Open, Vol. 7, No. 3, e015358, 01.03.2017.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF)

T2 - Rationale and design for a multicentre randomised trial

AU - Myles, Paul

AU - Bellomo, Rinaldo

AU - Corcoran, Tomas

AU - Forbes, Andrew

AU - Wallace, Sophie

AU - Peyton, Philip

AU - Christophi, Chris

AU - Story, David

AU - Leslie, Kate

AU - Serpell, Jonathan

AU - McGuinness, Shay

AU - Parke, Rachel

AU - Australian and New Zealand College of Anaesthetists Clinical Trials Network

AU - Australian and New Zealand Intensive Care Society Clinical Trials Group

PY - 2017/3/1

Y1 - 2017/3/1

N2 - 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 24â €..hour from the start of surgery in restrictive and liberal groups were ≤3.0â €..L and ≥5.4â €..L, respectively. Patient enrolment is complete, and follow-up for the primary end point is ongoing. The primary outcome is disability-free survival at 1â €..year after surgery, with disability defined as a persistent (at least 6â €..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.

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