Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version: Statistical analysis plan.

IF 1.9 4区医学 Q2 ANESTHESIOLOGY

Acta Anaesthesiologica Scandinavica Pub Date : 2024-01-01 Epub Date: 2023-09-11 DOI:10.1111/aas.14320

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

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引用次数: 0

Abstract

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.

查看原文本刊更多论文

呋塞米与安慰剂治疗重症监护患者体液超负荷--随机 GODIF 试验第二版：统计分析计划。

背景：液体超负荷与重症监护病房（ICU）患者死亡率的增加有关。GODIF 试验旨在评估在重症监护室中患有中度至重度液体超负荷的稳定期成人患者中使用呋塞米与安慰剂进行液体清除的益处和害处。本文介绍了第二版 GODIF 试验主要结果的详细统计分析计划：GODIF试验是一项国际性、多中心、随机、分层、盲法、平行组、实用性临床试验，将1000名中度至重度体液超负荷的ICU成人患者按1:1的比例分配给呋塞米与安慰剂。主要结果是随机分配后 90 天内的存活天数和出院天数。在90%的功率和5%的α水平下，我们可能会拒绝或检测到8%的改善。所有结果的主要分析都将在意向治疗人群中进行。对于主要结果，将采用 Kryger Jensen and Lange 方法对两个治疗组进行比较，并根据分层变量进行调整，辅以按方案治疗人群的敏感性分析，以及对预后变量的进一步调整。次要结果将采用多元线性回归、逻辑回归或 Kryger Jensen and Lange 方法进行分析，并酌情对分层变量进行调整：GODIF试验数据将增加使用呋塞米对ICU液体超负荷成人患者进行液体清除效果的确定性：试验注册：EudraCT 识别码：2019-004292-40 和 ClinicalTrials.org：NCT04180397。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Acta Anaesthesiologica Scandinavica 医学-麻醉学

CiteScore

4.30

自引率

9.50%

发文量

157

审稿时长

3-8 weeks

期刊介绍： Acta Anaesthesiologica Scandinavica publishes papers on original work in the fields of anaesthesiology, intensive care, pain, emergency medicine, and subjects related to their basic sciences, on condition that they are contributed exclusively to this Journal. Case reports and short communications may be considered for publication if of particular interest; also letters to the Editor, especially if related to already published material. The editorial board is free to discuss the publication of reviews on current topics, the choice of which, however, is the prerogative of the board. Every effort will be made by the Editors and selected experts to expedite a critical review of manuscripts in order to ensure rapid publication of papers of a high scientific standard.