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

• Status: Recruiting
• Trial end date: 2024-11-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morten H. Bestle
• Collaborators: Centre for Research in Intensive Care (CRIC); Copenhagen Trial Unit, Center for Clinical Intervention Research; Director Jakob Madsen´s and wife Olga Madsen´s foundation; Novo Nordisk A/S; University of Copenhagen
• Treatments: Furosemide

Criteria

Inclusion Criteria: ALL below must be met.

• Acute admission to the intensive care unit.

• Age ≥ 18 years of age

• Fluid overload defined as a positive cumulative fluid balance (according to the daily fluid charts) corresponding ≥ 5% of ideal body weight (calculated as: 22 x (height in meters)^2). 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 defined as 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.