Fluid Overload
Conditions
Keywords
Fluid overload, Fluid removal, Deresusciation, Diuretics, Fluid accumulation
Brief 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.
Detailed description
Fluid overload is a common and serious complication in patients admitted to the intensive care unit (ICU). A core element of therapy in the ICU is resuscitation with crystalloid solutions. In many cases fluid accumulate, and patients become fluid overloaded. Several observational studies indicate a detrimental effect of fluid overload in different clinical settings, including patients with acute kidney injury. It is unknown whether this association is causal or if the increased tendency to accumulate fluid is a marker of disease severity and thereby a higher risk of death. The investigators want to investigate this in critical ill patients with fluid overload of 5% or more by randomizing them to furosemide (diuretics) or placebo.
Interventions
DRUGFurosemide
Furosemide 10 mg/ml for injection/infusion
DRUGIsotonic saline
Isotonic saline used as placebo (injection/infusion)
Sponsors
Morten H. Bestle
University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Centre for Research in Intensive Care (CRIC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days alive and out of hospital | 90 days after randomization | Days alive and out of hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 90 days after randomization | All cause mortality |
| Mortality and life support | 90 days after randomization | Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy) |
| Mortality 1 year | one year after randomization | All cause mortality |
| Serious adverse events and reactions | 90 days | Number of participants with one or more serious adverse events and serious adverse reactions |
| Health related quality of life | 1 year after randomization | Measured using the European quality of Life 5D-5L questionnaire (5D-5L is the full name of the questionnaire). Index value of 1 represents full health and dead = 0. These value sets reflect the preferences of the general population. The European quality of life visual analogue scale is a self-reported assessment of the participant's health status. Scores on 100 = the best health you can imagine and 0 = the worst health you can imagine. |
| Cognitive function | 1 year after randomization | Cognitive function assessed by the Montreal Cognitive Assessment score. Using the mini test for telephone interview. The test and scoring system will soon be published from Montreal Cognitive Assessment. |
Countries
Australia, Czechia, Denmark, Finland, Iceland, Lithuania, Netherlands, Norway, Switzerland
Contacts
CONTACTSine Wichmann, MD
CONTACTMorten Bestle, MD
STUDY_CHAIRMorten Bestle, MD
Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital
Outcome results
None listed