Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version: Statistical analysis plan
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Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version : Statistical analysis plan. / 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.
I: Acta Anaesthesiologica Scandinavica, Bind 68, Nr. 1, 2024, s. 130-136.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version
T2 - Statistical analysis plan
AU - Wichmann, Sine
AU - Lange, Theis
AU - Perner, Anders
AU - Gluud, Christian
AU - Itenov, Theis S
AU - Berthelsen, Rasmus E
AU - Nebrich, Lars
AU - Wiis, Jørgen
AU - Brøchner, Anne C
AU - Nielsen, Louise G
AU - Behzadi, Meike T
AU - Damgaard, Kjeld
AU - Andreasen, Anne S
AU - Strand, Kristian
AU - Järvisalo, Mikko
AU - Strøm, Thomas
AU - Eschen, Camilla T
AU - Vang, Marianne L
AU - Hildebrandt, Thomas
AU - Andersen, Finn H
AU - Sigurdsson, Martin I
AU - Thomar, Katrin M
AU - Thygesen, Sandra K
AU - Troelsen, Thomas T
AU - Uusalo, Panu
AU - Jalkanen, Ville
AU - Illum, Dorte
AU - Sølling, Christoffer
AU - Keus, Frederik
AU - Pfortmueller, Carmen A
AU - Wahlin, Rebecka R
AU - Ostermann, Marlies
AU - Aneman, Anders
AU - Bestle, Morten H
N1 - © 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
PY - 2024
Y1 - 2024
N2 - 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. 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.
AB - 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. 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.
KW - Adult
KW - Humans
KW - Furosemide/therapeutic use
KW - Critical Care/methods
KW - Water-Electrolyte Imbalance
KW - Intensive Care Units
KW - Treatment Outcome
U2 - 10.1111/aas.14320
DO - 10.1111/aas.14320
M3 - Journal article
C2 - 37691474
VL - 68
SP - 130
EP - 136
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
SN - 0001-5172
IS - 1
ER -
ID: 378743717