title: Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial.
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.
  
  
  
  ClinicalTrials.gov identifier NCT01424150.
authors.affiliation: Alfred Hospital, Melbourne, Victoria, Australia.|Monash University, Melbourne, Victoria, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Myles
authors.affiliation: Monash University, Melbourne, Victoria, Australia.|Austin Hospital, Melbourne, Victoria, Australia.|The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
authors.affiliation: University of Western Australia, Melbourne, Victoria, Australia.
authors.forename: Tomas
authors.initials: T
authors.lastname: Corcoran
authors.affiliation: Monash University, Melbourne, Victoria, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Forbes
authors.affiliation: Alfred Hospital, Melbourne, Victoria, Australia.|Monash University, Melbourne, Victoria, Australia.
authors.forename: Sophie
authors.initials: S
authors.lastname: Wallace
authors.affiliation: Austin Hospital, Melbourne, Victoria, Australia.
authors.forename: Philip
authors.initials: P
authors.lastname: Peyton
authors.affiliation: Austin Hospital, Melbourne, Victoria, Australia.|The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Chris
authors.initials: C
authors.lastname: Christophi
authors.affiliation: The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Story
authors.affiliation: Monash University, Melbourne, Victoria, Australia.|The University of Melbourne, Melbourne, Victoria, Australia.|Royal Melbourne Hospital, Melbourne, Victoria, Australia.
authors.forename: Kate
authors.initials: K
authors.lastname: Leslie
authors.affiliation: Alfred Hospital, Melbourne, Victoria, Australia.|Monash University, Melbourne, Victoria, Australia.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Serpell
authors.affiliation: Auckland City Hospital, Auckland, New Zealand.
authors.forename: Shay
authors.initials: S
authors.lastname: McGuinness
authors.affiliation: Auckland City Hospital, Auckland, New Zealand.
authors.forename: Rachel
authors.initials: R
authors.lastname: Parke
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000328:Adult; D000368:Aged; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
keywords: ANAESTHETICS; INTENSIVE & CRITICAL CARE