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/37691474/Actively Recruiting
Led by Morten H. Bestle · Updated on 2026-06-03
1000
Participants Needed
29
Research Sites
50 weeks
Total Duration
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.
S
Sine Wichmann, MD
M
Morten Bestle, MD
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Morten H. Bestle
Lead Sponsor
University of Copenhagen
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
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
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/37691474/Sine Wichmann, Theis S Itenov, Rasmus E Berthelsen...
https://pubmed.ncbi.nlm.nih.gov/35898170/Morten H. Bestle
Lead Sponsor
University of Copenhagen
Collaborating Sponsor