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 :
Disability-free survival up to 1 year: survival and freedom from new-onset disability, the latter being a persistent (>6 months) reduction in functional status as defined by a 4-point or greater reduction in the 12-item version of WHODAS. Disability will be assessed by the participant, but if unable then we will use the proxy’s report. The date of onset of new disability will be recorded.
Funding: Australian NHMRC Project Grant
Registration: ClinicalTrials.gov Identifier: NCT01424150
For further information contact Sophie Wallace