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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,000
Furosemide 10 mg/ml for injection/infusion
Isotonic saline used as placebo (injection/infusion)
Days alive and out of hospital
Days alive and out of hospital
Time frame: 90 days after randomization
All cause mortality
All cause mortality
Time frame: 90 days after randomization
Mortality and life support
Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy)
Time frame: 90 days after randomization
Mortality 1 year
All cause mortality
Time frame: one year after randomization
Serious adverse events and reactions
Number of participants with one or more serious adverse events and serious adverse reactions
Time frame: 90 days
Health related quality of life
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.
Time frame: 1 year after randomization
Cognitive function
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.
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Department of Intensive Care, Liverpool Hospital
Sydney, Australia
NOT_YET_RECRUITINGDepartment of Intensive Care, Sygehus Sønderjylland Aabenraa
Aabenraa, Denmark
RECRUITINGDepartmen of Intensive Care
Aalborg, Denmark
RECRUITINGDepartment of Intensive Care, Aarhus University Hospital
Aarhus, Denmark
TERMINATEDDepartment of Intensive Care, Rigshospitalet
Copenhagen, Denmark
RECRUITINGDepartement of Intensive Care, Gentofte Hospital
Gentofte Municipality, Denmark
TERMINATEDDepartment of Intensive Care, Herlev Hospital
Herlev, Denmark
RECRUITINGDepartment of Intensive Care, Regionshospital Gødstrup
Herning, Denmark
RECRUITINGDepartment of Intensive Care, Nordsjællands hospital
Hillerød, Denmark
RECRUITINGDepartment of Intensive Care, Regionshospital Nordjylland Hjørring
Hjørring, Denmark
RECRUITING...and 14 more locations
Time frame: 1 year after randomization
Health related quality of life
Subjective assessment (unacceptable, neutral, acceptable)
Time frame: 1 year after randomization