Furosemide
DrugFurosemide 10 mg/ml for injection/infusion
Other names: Furix
NCT Number: NCT04180397
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Department of Intensive Care, Liverpool Hospital, Sydney, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ALL below must be met.
Exclusion criteria
Furosemide 10 mg/ml for injection/infusion
Other names: Furix
Isotonic saline used as placebo (injection/infusion)
Time frame: 90 days after randomization
Days alive and out of hospital
Time frame: 90 days after randomization
All cause mortality
Time frame: 90 days after randomization
Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy)
Time frame: one year after randomization
All cause mortality
Time frame: 90 days
Number of participants with one or more serious adverse events and serious adverse reactions
Time frame: 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.
Time frame: 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.
Time frame: 1 year after randomization
Subjective assessment (unacceptable, neutral, acceptable)
Contact information is provided by the study sponsor or research team.
Morten Bestle, MD
CONTACT
Sine Wichmann, MD
CONTACT
Morten H. Bestle
Other
Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).
Acronym: GODIF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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