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)
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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). / 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.
In: Acta Anaesthesiologica Scandinavica, Vol. 66, No. 9, 2022, p. 1138-1145.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload
T2 - A trial protocol for a randomised, blinded trial (GODIF trial)
AU - Wichmann, Sine
AU - Itenov, Theis S.
AU - Berthelsen, Rasmus E.
AU - Lange, Theis
AU - Perner, Anders
AU - Gluud, Christian
AU - Lawson-Smith, Pia
AU - Nebrich, Lars
AU - Wiis, Jørgen
AU - Brøchner, Anne C.
AU - Hildebrandt, Thomas
AU - Behzadi, Meike T.
AU - Strand, Kristian
AU - Andersen, Finn H.
AU - Strøm, Thomas
AU - Järvisalo, Mikko
AU - Damgaard, Kjeld A.J.
AU - Vang, Marianne L.
AU - Wahlin, Rebecka R.
AU - Sigurdsson, Martin I.
AU - Thormar, Katrin M.
AU - Ostermann, Marlies
AU - Keus, Frederik
AU - Bestle, Morten H.
N1 - Publisher Copyright: © 2022 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - critical care
KW - de-resuscitation
KW - diuretics
KW - fluid accumulation
KW - fluid overload
KW - fluid removal
KW - furosemide
KW - intensive care
KW - loop diuretics
KW - protocol
KW - randomised clinical trial
U2 - 10.1111/aas.14121
DO - 10.1111/aas.14121
M3 - Journal article
C2 - 35898170
AN - SCOPUS:85135607126
VL - 66
SP - 1138
EP - 1145
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
SN - 0001-5172
IS - 9
ER -
ID: 317046847