A1 Vertaisarvioitu alkuperäisartikkeli tieteellisessä lehdessä
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)
Tekijät: Wichmann Sine, Itenov Theis S., Berthelsen Rasmus E., Lange Theis, Perner Anders, Gluud Christian, Lawson-Smith Pia, Nebrich Lars, Wiis Jørgen, Brøchner Anne C., Hildebrandt Thomas, Behzadi Meike T., Strand Kristian, Andersen Finn H., Strøm Thomas, Järvisalo Mikko, Damgaard Kjeld A. J., Vang Marianne L., Wahlin Rebecka R., Sigurdsson Martin I., Thormar Katrin M., Ostermann Marlies, Keus Frederik, Bestle Morten H.
Kustantaja: Wiley-Blackwell Publishing, Inc.
Julkaisuvuosi: 2022
Journal: Acta Anaesthesiologica Scandinavica
Tietokannassa oleva lehden nimi: Acta anaesthesiologica Scandinavica
Lehden akronyymi: Acta Anaesthesiol Scand
Vuosikerta: 66
Numero: 9
Aloitussivu: 1138
Lopetussivu: 1145
ISSN: 0001-5172
eISSN: 1399-6576
DOI: https://doi.org/10.1111/aas.14121
Verkko-osoite: https://onlinelibrary.wiley.com/doi/10.1111/aas.14121
Rinnakkaistallenteen osoite: https://research.utu.fi/converis/portal/detail/Publication/176278407
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.\ngov 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.
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