Opin vísindi

Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload : A trial protocol for a randomised, blinded trial (GODIF trial)

Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload : A trial protocol for a randomised, blinded trial (GODIF trial)


Title: Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload : A trial protocol for a randomised, blinded trial (GODIF trial)
Author: Wichmann, Sine
Itenov, Theis S.
Berthelsen, Rasmus E.
Lange, Theis
Perner, Anders
Gluud, Christian
Lawson-Smith, Pia
Nebrich, Lars
Wiis, Jørgen
Brøchner, Anne C.
... 14 more authors Show all authors
Date: 2022-08-09
Language: English
Scope: 8
Department: Faculty of Medicine
Perioperative Services
Series: Acta Anaesthesiologica Scandinavica; 66(9)
ISSN: 0001-5172
DOI: https://doi.org/10.1111/aas.14121
Subject: critical care; de-resuscitation; diuretics; fluid accumulation; fluid overload; fluid removal; furosemide; intensive care; loop diuretics; protocol; randomised clinical trial; Sodium Potassium Chloride Symporter Inhibitors; Humans; Water-Electrolyte Imbalance; Treatment Outcome; Randomized Controlled Trials as Topic; Critical Care/methods; Systematic Reviews as Topic; Quality of Life; Adult; Furosemide/therapeutic use; Goals; Anesthesiology and Pain Medicine
URI: https://hdl.handle.net/20.500.11815/3756

Show full item record

Citation:

Wichmann , S , Itenov , T S , Berthelsen , R E , Lange , T , Perner , A , Gluud , C , Lawson-Smith , P , Nebrich , L , Wiis , J , Brøchner , A C , Hildebrandt , T , Behzadi , M T , Strand , K , Andersen , F H , Strøm , T , Järvisalo , M , Damgaard , K A J , Vang , M L , Wahlin , R R , Sigurdsson , M I , Thormar , K M , Ostermann , M , Keus , F & Bestle , M H 2022 , ' Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload : A trial protocol for a randomised, blinded trial (GODIF trial) ' , Acta Anaesthesiologica Scandinavica , vol. 66 , no. 9 , pp. 1138-1145 . https://doi.org/10.1111/aas.14121

Abstract:

Background: Fluid overload is a risk factor for mortality in intensive care unit (ICU) patients. Administration of loop diuretics is the predominant treatment of fluid overload, but evidence for its benefit is very uncertain when assessed in a systematic review of randomised clinical trials. The GODIF trial will assess the benefits and harms of goal directed fluid removal with furosemide versus placebo in ICU patients with fluid overload. Methods: An investigator-initiated, international, randomised, stratified, blinded, parallel-group trial allocating 1000 adult ICU patients with fluid overload to infusion of furosemide versus placebo. The goal is to achieve a neutral fluid balance. The primary outcome is days alive and out of hospital 90 days after randomisation. Secondary outcomes are all-cause mortality at day 90 and 1-year after randomisation; days alive at day 90 without life support; number of participants with one or more serious adverse events or reactions; health-related quality of life and cognitive function at 1-year follow-up. A sample size of 1000 participants is required to detect an improvement of 8% in days alive and out of hospital 90 days after randomisation with a power of 90% and a risk of type 1 error of 5%. The conclusion of the trial will be based on the point estimate and 95% confidence interval; dichotomisation will not be used. ClinicalTrials.gov identifier: NCT04180397. Perspective: The GODIF trial will provide important evidence of possible benefits and harms of fluid removal with furosemide in adult ICU patients with fluid overload.

Description:

Funding Information: SW has received a grant from Merchant Jakob Ehrenreich and wife Grete Ehrenreich's Foundation to production of trial drug for the GODIF trial. AP has received research funding from the Novo Nordisk Foundation, Health Insurance Denmark (Sygeforsikringen Danmark), Fresenius Kabi, Denmark, and Pfizer, Denmark. MO has received research funding from Fresenius Medical Care, Baxter and Biomerieux. MHB has received research funding for the GODIF trial from Novo Nordisk Foundation, Jakob Madsen's and wife Olga Madsen's Foundation, Svend Andersen's Foundation, and Health Insurance Denmark (Sygeforsikringen Danmark). No authors received any financial gain. All other authors declared no conflicts of interest. Publisher Copyright: © 2022 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

Files in this item

This item appears in the following Collection(s)