Brief Summary
Design:
This will be a large, randomized, parallel-group, controlled trial. After stratification by centre
and planned ICU/HDU admission (or not), patients will be randomly assigned from a
computer-generated list (1:1) to either a Restrictive or Liberal fluid Group.
Group 1 = Restrictive fluid regimen (intraoperative and 1st 24 h ≈2.5 L)
Group 2 = Liberal fluid regimen (intraoperative and 1st 24 h ≈5.5 L)
Sample Size: 2800 patients
Study Duration: 3 years
Primary Endpoint :
The primary end point of the trial is disability-free survival at 1 year after surgery. Disability is defined as a persistent (at least 6 months) impairment in health status, as measured by the 12-item WHODAS score, of at least 24 points when using response scores of 1–5 for each item, reflecting a disability level of at least 25% and being the threshold point between ‘disabled’ and ‘not disabled’ as per WHO guidelines.
Funding: Australian NHMRC Project Grant
Registration: ClinicalTrials.gov Identifier: NCT01424150
For further information contact Sophie Wallace
