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Войти в исследования Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version: Statistical analysis plan.
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Wichmann Sine, Lange Theis, Perner Anders, Gluud Christian, Itenov Theis S, Berthelsen Rasmus E, Nebrich Lars, Wiis Jørgen, Brøchner Anne C, Nielsen Louise G, Behzadi Meike T, Damgaard Kjeld, Andreasen Anne S, Strand Kristian, Järvisalo Mikko, Strøm Thomas, Eschen Camilla T, Vang Marianne L, Hildebrandt Thomas, Andersen Finn H, Sigurdsson Martin I, Thomar Katrin M, Thygesen Sandra K, Troelsen Thomas T, Uusalo Panu, Jalkanen Ville, Illum Dorte, Sølling Christoffer, Keus Frederik, Pfortmueller Carmen A, Wahlin Rebecka R, Ostermann Marlies, Aneman Anders, Bestle Morten H
Аннотация
METHODS: The GODIF trial is an international, multi-centre, randomised, stratified, blinded, parallel-group, pragmatic clinical trial, allocating 1000 adult ICU patients with moderate to severe fluid overload 1:1 to furosemide versus placebo. The primary outcome is days alive and out of hospital within 90 days post-randomisation. With a power of 90% and an alpha level of 5%, we may reject or detect an improvement of 8%. The primary analyses of all outcomes will be performed in the intention-to-treat population. For the primary outcome, the Kryger Jensen and Lange method will be used to compare the two treatment groups adjusted for stratification variables supplemented with sensitivity analyses in the per-protocol population and with further adjustments for prognostic variables. Secondary outcomes will be analysed with multiple linear regressions, logistic regressions or the Kryger Jensen and Lange method as suitable with adjustment for stratification variables.
CONCLUSION: The GODIF trial data will increase the certainty about the effects of fluid removal using furosemide in adult ICU patients with fluid overload.
TRIAL REGISTRATIONS: EudraCT identifier: 2019-004292-40 and ClinicalTrials.org: NCT04180397.