Furosemide versus placebo for fluid overload in intensive care patients—The randomised GODIF trial second version: Statistical analysis plan
Study context
- Population
- Stable adult intensive care unit (ICU) patients with moderate to severe fluid overloadplanned, 1:1
- Participants
- 1,000 patients
- Planned comparison
- Furosemide vs placebo for fluid removal
- Primary endpoint
- Days alive and out of hospital
- Follow-up
- 90 days post-randomisation
Methodological detailsinternational, multicentre, stratified, blinded, parallel-group, pragmatic, Power 90%, alpha 5% to detect or reject an improvement of 8%, Primary analyses in ITT population; primary outcome compared with Kryger Jensen and Lange method adjusted for stratification variables, Sensitivity analyses in per-protocol population and with further adjustment for prognostic variables, Secondary outcomes analysed with multiple linear regressions, logistic regressions or Kryger Jensen and Lange method, adjusted for stratification variables
- International
- Multicentre
- Stratified
- Blinded
- Parallel-group
- Pragmatic
- Power 90%, alpha 5% to detect or reject an improvement of 8%
- Primary analyses in ITT population; primary outcome compared with Kryger Jensen and Lange method adjusted for stratification variables
- Sensitivity analyses in per-protocol population and with further adjustment for prognostic variables
- Secondary outcomes analysed with multiple linear regressions, logistic regressions or Kryger Jensen and Lange method, adjusted for stratification variables
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Furosemide versus placebo for fluid overload in intensive care patients—The randomised GODIF trial second version: Statistical analysis plan. Acta Anaesthesiol Scand. Published 11 September 2023. doi:10.
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