Treatment of fluid overload in critically ill adult patients in intensive care unit. MedDRA version: 22.1 Level: LLT Classification code 10015766 Term: Extracellular fluid increased System Organ Class: 100000004861 MedDRA version: 20.0 Level: LLT Classification code 10016808 Term: Fluid retention in tissues System Organ Class: 100000004861 MedDRA version: 24.0 Level: LLT Classification code 10022608 Term: Interstitial fluid increased System Organ Class: 100000004861 MedDRA version: 21.1 Leve
Conditions
Interventions
Product Name: Furosemide
Pharmaceutical Form: Infusion
INN or Proposed INN: FUROSEMIDE
Other descriptive name: loop diuretics
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equa
Sponsors
Department of Anesthesia and Intensive Care Medicine, Nordsjællands hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the parameters must be met: • Acute admission to the ICU. • Age = 18 years of age. • Fluid accumulation estimated according to daily fluid charts, the cumulative fluid balance, development in body weight, and clinical examination corresponding = 5% of ideal body weight • Clinical stable defined as assessed by the clinician (minimum criteria MAP > 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate =65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: • Known allergy to furosemide or sulphonamides. • Known pre-hospitalization advanced chronic kidney disease (eGFR155 mmol/l). • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Days alive and out of hospital at day 90 after randomisation.;Timepoint(s) of evaluation of this end point: 90 days post-randomisation.;Main Objective: To assess benefits and harms of goal directed fluid removal with furosemide versus placebo on patient-important outcome measures in adult ICU patients with moderate to severe fluid overload. The primary objective is to determine, if forced fluid removal with furosemide compared to placebo (spontaneous fluid excretion) will increase the number of days alive and out of hospital at 90 days. ;Secondary Objective: To investigate if goal directed fluid removal compared to placebo in adult ICU patients with fluid overload will change the: 1. All-cause mortality at day 90 after randomization. 2. Days alive at day 90 without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy). 3. All-cause mortality at 1-year after randomization. 4. Number of participants with one or more serious adverse events (SAEs) and serious adverse reactions (SARs) to furosemide. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: End point number 1, 2, and 3: 90 days post-randomisation End point number: 3 - 1 year post-randomisation;Secondary end point(s): 1. All-cause mortality at day 90 after randomisation. 2. Days alive at day 90 without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy). 3. All-cause mortality at 1-year after randomization. 4. Number of participants with one or more serious adverse events (SAEs) and serious adverse reactions (SARs) to furosemide. | — |
Countries
Denmark, Finland, Norway
Contacts
Public ContactMorten Bestle
Department of Anesthesia and Intensive Care Medicine, Nordsjællands hospital
Outcome results
None listed