{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T18:08:00Z","timestamp":1772388480562,"version":"3.50.1"},"reference-count":35,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T00:00:00Z","timestamp":1694390400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009907","name":"Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009907","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009708","name":"Novo Nordisk Fonden","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009708","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100007371","name":"Svend Andersen Fonden","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007371","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Anaesthesiol Scand"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The GODIF trial is an international, multi\u2010centre, randomised, stratified, blinded, parallel\u2010group, 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\u2009days post\u2010randomisation. 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\u2010to\u2010treat 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\u2010protocol 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The GODIF trial data will increase the certainty about the effects of fluid removal using furosemide in adult ICU patients with fluid overload.<\/jats:p><jats:p>Trial Registrations: EudraCT identifier: 2019\u2010004292\u201040 and <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.org\">ClinicalTrials.org<\/jats:ext-link>: NCT04180397.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aas.14320","type":"journal-article","created":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T07:03:35Z","timestamp":1694415815000},"page":"130-136","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Furosemide versus placebo for fluid overload in intensive care patients\u2014The randomised <scp>GODIF<\/scp> trial second version: Statistical analysis plan"],"prefix":"10.1111","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0360-8655","authenticated-orcid":false,"given":"Sine","family":"Wichmann","sequence":"first","affiliation":[{"name":"Department of Anaesthesia and Intensive Care Copenhagen University Hospital\u2014North Zealand  Hilleroed Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theis","family":"Lange","sequence":"additional","affiliation":[{"name":"Section of Biostatistics, Department of Public Health University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anders","family":"Perner","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Copenhagen University Hospital\u2014Rigshospitalet  Copenhagen Denmark"},{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Gluud","sequence":"additional","affiliation":[{"name":"Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region Copenhagen University Hospital\u2014Rigshospitalet  Copenhagen Denmark"},{"name":"The Faculty of Health Sciences, Department of Regional Health Research University of Southern Denmark  Odense Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theis S.","family":"Itenov","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia Copenhagen University Hospital\u2014Bispebjerg  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rasmus E.","family":"Berthelsen","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"Nebrich","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care Zealand University Hospital  Koege Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00f8rgen","family":"Wiis","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne C.","family":"Br\u00f8chner","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia and Intensive Care University Hospital of Southern Denmark  Kolding Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louise G.","family":"Nielsen","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Odense University Hospital  Odense Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meike 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