Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).
Morten H. Bestle
1,000 participants
Aug 17, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria12
- 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.
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Interventions
Furosemide 10 mg/ml for injection/infusion
Isotonic saline used as placebo (injection/infusion)
Locations(24)
View Full Details on ClinicalTrials.gov
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NCT04180397