Goal-directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload: A randomised, blinded trial (GODIF trial—First version)
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Goal-directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload : A randomised, blinded trial (GODIF trial—First version). / Wichmann, Sine; Schønemann-Lund, Martin; Perner, Anders; Itenov, Theis S.; Lange, Theis; Gluud, Christian; Berthelsen, Rasmus E.; Brøchner, Anne C.; Wiis, Jørgen; Bestle, Morten H.
I: Acta Anaesthesiologica Scandinavica, Bind 67, Nr. 4, 2023, s. 470-478.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Goal-directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload
T2 - A randomised, blinded trial (GODIF trial—First version)
AU - Wichmann, Sine
AU - Schønemann-Lund, Martin
AU - Perner, Anders
AU - Itenov, Theis S.
AU - Lange, Theis
AU - Gluud, Christian
AU - Berthelsen, Rasmus E.
AU - Brøchner, Anne C.
AU - Wiis, Jørgen
AU - Bestle, Morten H.
N1 - Publisher Copyright: © 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
PY - 2023
Y1 - 2023
N2 - Background: Salt and water accumulation leading to fluid overload is associated with increased mortality in intensive care unit (ICU) patients, but diuretics' effects on patient outcomes are uncertain. In this first version of the GODIF trial, we aimed to assess the effects of goal-directed fluid removal with furosemide versus placebo in adult ICU patients with fluid overload. Methods: We conducted a multicentre, randomised, stratified, parallel-group, blinded, placebo-controlled trial in clinically stable, adult ICU patients with at least 5% fluid overload. Participants were randomised to furosemide versus placebo infusion aiming at achieving neutral cumulative fluid balance as soon as possible. The primary outcome was the number of days alive and out of the hospital at 90 days. Results: The trial was terminated after the enrolment of 41 of 1000 participants because clinicians had difficulties using cumulative fluid balance as the only estimate of fluid status (32% of participants had their initially registered cumulative fluid balance adjusted and 29% experienced one or more protocol violations). The baseline cumulative fluid balance was 6956 ml in the furosemide group and 6036 ml in the placebo group; on day three, the cumulative fluid balances were 1927 ml and 5139 ml. The median number of days alive and out of hospital at day 90 was 50 days in the furosemide group versus 45 days in the placebo group (mean difference 1 day, 95% CI -19 to 21, p-value.94). Conclusions: The use of cumulative fluid balance as the only estimate of fluid status appeared too difficult to use in clinical practice. We were unable to provide precise estimates for any outcomes as only 4.1% of the planned sample size was randomised.
AB - Background: Salt and water accumulation leading to fluid overload is associated with increased mortality in intensive care unit (ICU) patients, but diuretics' effects on patient outcomes are uncertain. In this first version of the GODIF trial, we aimed to assess the effects of goal-directed fluid removal with furosemide versus placebo in adult ICU patients with fluid overload. Methods: We conducted a multicentre, randomised, stratified, parallel-group, blinded, placebo-controlled trial in clinically stable, adult ICU patients with at least 5% fluid overload. Participants were randomised to furosemide versus placebo infusion aiming at achieving neutral cumulative fluid balance as soon as possible. The primary outcome was the number of days alive and out of the hospital at 90 days. Results: The trial was terminated after the enrolment of 41 of 1000 participants because clinicians had difficulties using cumulative fluid balance as the only estimate of fluid status (32% of participants had their initially registered cumulative fluid balance adjusted and 29% experienced one or more protocol violations). The baseline cumulative fluid balance was 6956 ml in the furosemide group and 6036 ml in the placebo group; on day three, the cumulative fluid balances were 1927 ml and 5139 ml. The median number of days alive and out of hospital at day 90 was 50 days in the furosemide group versus 45 days in the placebo group (mean difference 1 day, 95% CI -19 to 21, p-value.94). Conclusions: The use of cumulative fluid balance as the only estimate of fluid status appeared too difficult to use in clinical practice. We were unable to provide precise estimates for any outcomes as only 4.1% of the planned sample size was randomised.
KW - diuretics
KW - fluid accumulation
KW - fluid overload
KW - fluid therapy
KW - furosemide
KW - intensive care
U2 - 10.1111/aas.14196
DO - 10.1111/aas.14196
M3 - Journal article
C2 - 36636797
AN - SCOPUS:85147221614
VL - 67
SP - 470
EP - 478
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
SN - 0001-5172
IS - 4
ER -
ID: 336447342