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Clinical Trials in the Netherlands / NCT04180397
Recruiting Phase 4

Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.

NCT04180397 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Morten H. Bestle
Phase
Phase 4
Started
2020-08-17
Last updated
2026-06-03

Condition(s) studied

Fluid Overload

Investigational drug(s) / intervention(s)

Furosemide →Isotonic saline

Furosemide: Furosemide 10 mg/ml for injection/infusion

Isotonic saline: Isotonic saline used as placebo (injection/infusion)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: ALL below must be met. * Acute admission to the intensive care unit. * Age ≥ 18 years of age * Fluid overload ≥ 5% of ideal body weight. If possible, all fluids administered before admission to the intensive care unit are to be included in the calculation of cumulative fluid balance. * Clinical stable (minimum criteria: MAP \> 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate \< 4.0 mmol/L) Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
Department of Intensive Care, Liverpool Hospital Sydney Australia Recruiting
Department of Intensive Care, Royal North Shore Hospital Sydney Australia Recruiting
Department of Intensive Care, University Hospital of Ostrava Ostrava Czechia Not Yet Recruiting
Department of Intensive Care, University Hospital of Pilsen Pilsen Czechia Recruiting
Department of Intensive Care, IKEM Prague Czechia Recruiting
Department of Intensive Care, Sygehus Sønderjylland Aabenraa Aabenraa Denmark Terminated
Departmen of Intensive Care Aalborg Denmark Recruiting
Department of Intensive Care, Aarhus University Hospital Aarhus Denmark Terminated
Department of Intensive Care, Rigshospitalet Copenhagen Denmark Recruiting
Departement of Intensive Care, Gentofte Hospital Gentofte Municipality Denmark Terminated
Department of Intensive Care, Herlev Hospital Herlev Denmark Recruiting
Department of Intensive Care, Regionshospital Gødstrup Herning Denmark Recruiting
Department of Intensive Care, Nordsjællands hospital Hillerød Denmark Recruiting
Department of Intensive Care, Regionshospital Nordjylland Hjørring Hjørring Denmark Recruiting
Department of Intensive Care Kolding Denmark Recruiting
Department of Intensive Care, Zealand University hospital Køge Denmark Recruiting
Department of Intensive Care Odense Denmark Recruiting
Department of Intensive Care, Regionshospitalet Randers Randers Denmark Recruiting
Department of Intensive Care, University Hospital Zealand, Roskilde Roskilde Denmark Recruiting
Department of Intensive Care Vejle Denmark Withdrawn
Regionshospitalet Viborg Viborg Denmark Recruiting
Department of Intensive Care, Tampere University Hospital Tampere Finland Terminated
Department of Intensive Care Turku Finland Terminated
Department of Intensive Care, Landspitali National University Hospital of Iceland Reykjavik Iceland Terminated
Vilnius University Hospital Santaros Clinics Vilnius Lithuania Recruiting
Department of Critical Care, University Medical Center Groningen Groningen Netherlands Recruiting
Department of Intensive Care, Ålesund Sjukehus Ålesund Norway Terminated
Department of Intensive Care, Stavanger University Hospital Stavanger Norway Terminated
Department of Intensive Care, Inselspital Bern Switzerland Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04180397 on ClinicalTrials.gov ↗ ← All trials in the Netherlands