Sine Wichmann, Theis Lange, Anders Perner, Christian Gluud, Theis S Itenov, Rasmus E Berthelsen, Lars Nebrich, Jørgen Wiis, Anne C Brøchner, Louise G Nielsen, Meike T Behzadi, Kjeld Damgaard, Anne S Andreasen, Kristian Strand, Mikko Järvisalo, Thomas Strøm, Camilla T Eschen, Marianne L Vang, Thomas Hildebrandt, Finn H Andersen, Martin I Sigurdsson, Katrin M Thomar, Sandra K Thygesen, Thomas T Troelsen, Panu Uusalo, Ville Jalkanen, Dorte Illum, Christoffer Sølling, Frederik Keus, Carmen A Pfortmueller, Rebecka R Wahlin, Marlies Ostermann, Anders Aneman, Morten H Bestle
BACKGROUND: Fluid overload is associated with increased mortality in intensive care unit (ICU) patients. The GODIF trial aims to assess the benefits and harms of fluid removal with furosemide versus placebo in stable adult patients with moderate to severe fluid overload in the ICU. This article describes the detailed statistical analysis plan for the primary results of the second version of the GODIF trial. 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...
January 2024: Acta Anaesthesiologica Scandinavica