Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Fluid Overload
In brief
This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.
Key facts
- Study ID
- NCT04180397
- Run by
- Morten H. Bestle
- People needed
- 1000
- Starts
- 2020-08-17
- Expected to finish
- 2028-04-15
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Known allergy to furosemide or sulphonamides.
- Known pre-hospitalization advanced chronic kidney disease (eGFR < 30 mL/minute/1.73 m\^2 or chronic RRT).
- Ongoing renal replacement therapy.
- Anuria > 6 hours.
- Rhabdomyolysis with indication for forced diuresis
- Ongoing life-threatening bleeding as these patients need specific fluid/blood product strategies.
- Acute burn injury of more than 10% of the body surface area as these patients need a specific fluid strategy.
- Severe dysnatremia (p-Na < 120 or > 155 mmol/L) as these patients need a specific fluid strategy.
- Severe hepatic failure as per the clinical team.
- Patients undergoing forced treatment.
- Fertile women (women < 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG.
- Consent not obtainable as per the model approved for the specific trial site.
Where it is running
- Department of Intensive Care, Inselspital — Bern, Switzerland (enrolling)
- Department of Intensive Care, Royal North Shore Hospital — Sydney, Australia (enrolling)
- Department of Intensive Care, Regionshospital Nordjylland Hjørring — Hjørring, Denmark (enrolling)
- Department of Intensive Care — Kolding, Denmark (enrolling)
- Department of Intensive Care, Zealand University hospital — Køge, Denmark (enrolling)
- Department of Intensive Care — Odense, Denmark (enrolling)
- Department of Intensive Care, Regionshospitalet Randers — Randers, Denmark (enrolling)
- Department of Intensive Care, University Hospital Zealand, Roskilde — Roskilde, Denmark (enrolling)
- Regionshospitalet Viborg — Viborg, Denmark (enrolling)
- Vilnius University Hospital Santaros Clinics — Vilnius, Lithuania (enrolling)
- Department of Critical Care, University Medical Center Groningen — Groningen, Netherlands (enrolling)
- Department of Intensive Care, Liverpool Hospital — Sydney, Australia (enrolling)
- Department of Intensive Care, University Hospital of Pilsen — Pilsen, Czechia (enrolling)
- Department of Intensive Care, IKEM — Prague, Czechia (enrolling)
- Departmen of Intensive Care — Aalborg, Denmark (enrolling)
- Department of Intensive Care, Rigshospitalet — Copenhagen, Denmark (enrolling)
- Department of Intensive Care, Herlev Hospital — Herlev, Denmark (enrolling)
- Department of Intensive Care, Regionshospital Gødstrup — Herning, Denmark (enrolling)
- Department of Intensive Care, Nordsjællands hospital — Hillerød, Denmark (enrolling)
- Department of Intensive Care, University Hospital of Ostrava — Ostrava, Czechia
- Department of Intensive Care, Ålesund Sjukehus — Ålesund, Norway
- Department of Intensive Care — Vejle, Denmark
- Department of Intensive Care, Sygehus Sønderjylland Aabenraa — Aabenraa, Denmark
- Department of Intensive Care, Stavanger University Hospital — Stavanger, Norway
- Department of Intensive Care, Aarhus University Hospital — Aarhus, Denmark
Full record on ClinicalTrials.gov
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