Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
Launched by MORTEN H. BESTLE · Nov 25, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a medication called furosemide, which helps remove excess fluid from the body, in critically ill patients who have too much fluid in their system. The trial is comparing the results of patients receiving furosemide to those receiving a placebo (a treatment that does not contain the active medication). The goal is to see how well furosemide works in helping these patients get rid of excess fluid safely.
To be eligible for this trial, patients must be at least 18 years old, currently admitted to the intensive care unit, and have a fluid overload of at least 5% of their ideal body weight. Participants will receive treatment until the extra fluid is removed from their bodies. It’s important to note that patients with certain conditions, such as severe kidney problems or ongoing life-threatening issues, cannot participate. If you or a loved one is in the ICU and meets these criteria, this study could help improve our understanding of managing fluid overload in critically ill patients.
Gender
ALL
Eligibility criteria
- • 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.
About Morten H. Bestle
Morten H. Bestle is a dedicated clinical trial sponsor committed to advancing medical research through innovative study designs and rigorous methodologies. With a focus on enhancing patient outcomes, the organization specializes in the development and management of clinical trials across various therapeutic areas. Morten H. Bestle prioritizes collaboration with healthcare professionals and research institutions to ensure the highest standards of ethical conduct and scientific integrity. Through a steadfast commitment to excellence, the sponsor aims to contribute meaningful advancements in healthcare and support the journey from research to real-world application.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aarhus, , Denmark
Viborg, , Denmark
Copenhagen, , Denmark
Hillerød, , Denmark
ålesund, , Norway
Aabenraa, , Denmark
Aalborg, , Denmark
Hjørring, , Denmark
Kolding, , Denmark
Køge, , Denmark
Odense, , Denmark
Roskilde, , Denmark
Vejle, , Denmark
Turku, , Finland
Stavanger, , Norway
Aarhus, , Denmark
Aabenraa, , Denmark
Herning, , Denmark
Hillerød, , Denmark
Hjørring, , Denmark
Randers, , Denmark
Roskilde, , Denmark
Tampere, , Finland
Reykjavík, , Iceland
ålesund, , Norway
Aarhus, , Denmark
Gentofte, , Denmark
Herlev, , Denmark
Groningen, , Netherlands
Bern, , Switzerland
Sidney, , Australia
Patients applied
Trial Officials
Morten Bestle, MD
Study Chair
Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials