Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version: Statistical analysis plan.
Sine Wichmann, Theis Lange, Anders Perner...
https://pubmed.ncbi.nlm.nih.gov/37691474Actively Recruiting
Led by Morten H. Bestle · Updated on 2026-06-03
1000
Participants Needed
29
Research Sites
50 weeks
Total Duration
M
Morten H. Bestle
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
Researchers are evaluating the benefits and risks of using furosemide, a diuretic, compared to a placebo in critically ill adult patients who experience fluid overload in the intensive care unit (ICU). Fluid overload, a common complication in ICU patients, can worsen outcomes especially in those with acute kidney injury. The study aims to determine if reducing excess fluid with furosemide improves patient health or if fluid overload is simply a marker of severe illness. Participants are randomly assigned to receive either furosemide or a placebo (isotonic saline) through intravenous infusion. The furosemide group receives a bolus dose followed by an infusion adjusted to target a negative fluid balance of 1 ml per kg per hour, with fluid balance monitored three times daily. The placebo group receives saline dosed and adjusted by the same protocol. Treatment continues until the excess fluid is removed and fluid balance is neutral. During the study, participants will be closely monitored for fluid balance and clinical stability. Researchers will assess outcomes including days alive and out of hospital within 90 days, mortality rates up to one year, serious adverse events, quality of life, and cognitive function. The study involves a randomized, blinded design to compare the effects of furosemide versus placebo over a one-year follow-up period.
CONDITIONS
Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until fluid balance is assessed neutral
Participants receive goal directed fluid removal with either furosemide or placebo infusion to achieve a negative fluid balance, monitored multiple times daily.
Daily assessments with fluid balance calculated three times per day
Duration - Up to 1 year after randomization
Participants are followed up for survival, adverse events, and quality of life outcomes after treatment ends.
Assessments at 90 days and 1 year after randomization
Total: 29 locations
1
Department of Intensive Care, Liverpool Hospital
Sydney, Australia
Actively Recruiting
2
Department of Intensive Care, Royal North Shore Hospital
Sydney, Australia
Actively Recruiting
3
Department of Intensive Care, University Hospital of Ostrava
Ostrava, Czechia
Not Yet Recruiting
4
Department of Intensive Care, University Hospital of Pilsen
Pilsen, Czechia
Actively Recruiting
5
Department of Intensive Care, IKEM
Prague, Czechia
Actively Recruiting
6
Department of Intensive Care, Sygehus Sønderjylland Aabenraa
Aabenraa, Denmark
Terminated
7
Departmen of Intensive Care
Aalborg, Denmark, 9000
Actively Recruiting
8
Department of Intensive Care, Aarhus University Hospital
Aarhus, Denmark
Terminated
9
Department of Intensive Care, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
10
Departement of Intensive Care, Gentofte Hospital
Gentofte Municipality, Denmark
Terminated
11
Department of Intensive Care, Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
12
Department of Intensive Care, Regionshospital Gødstrup
Herning, Denmark, 7400
Actively Recruiting
13
Department of Intensive Care, Nordsjællands hospital
Hillerød, Denmark
Actively Recruiting
14
Department of Intensive Care, Regionshospital Nordjylland Hjørring
Hjørring, Denmark
Actively Recruiting
15
Department of Intensive Care
Kolding, Denmark, 6000
Actively Recruiting
16
Department of Intensive Care, Zealand University hospital
Køge, Denmark, 4600
Actively Recruiting
17
Department of Intensive Care
Odense, Denmark, 5000
Actively Recruiting
18
Department of Intensive Care, Regionshospitalet Randers
Randers, Denmark, 8930
Actively Recruiting
19
Department of Intensive Care, University Hospital Zealand, Roskilde
Roskilde, Denmark
Actively Recruiting
20
Department of Intensive Care
Vejle, Denmark, 7100
Withdrawn
21
Regionshospitalet Viborg
Viborg, Denmark, 8800
Actively Recruiting
22
Department of Intensive Care, Tampere University Hospital
Tampere, Finland, 33520
Terminated
23
Department of Intensive Care
Turku, Finland
Terminated
24
Department of Intensive Care, Landspitali National University Hospital of Iceland
Reykjavik, Iceland
Terminated
25
Vilnius University Hospital Santaros Clinics
Vilnius, Lithuania
Actively Recruiting
26
Department of Critical Care, University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
27
Department of Intensive Care, Ålesund Sjukehus
Ålesund, Norway
Terminated
28
Department of Intensive Care, Stavanger University Hospital
Stavanger, Norway, 4068
Terminated
29
Department of Intensive Care, Inselspital
Bern, Switzerland
Actively Recruiting
S
Sine Wichmann, MD
M
Morten Bestle, MD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sine Wichmann, Theis Lange, Anders Perner...
https://pubmed.ncbi.nlm.nih.gov/37691474Sine Wichmann, Theis S Itenov, Rasmus E Berthelsen...
https://pubmed.ncbi.nlm.nih.gov/35898170