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Search / Trial NCT04180397

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

Fluid Overload Fluid Removal Deresusciation Diuretics Fluid Accumulation

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.

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

0 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

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