Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE4
Study ID
NCT04180397
Intervention or treatment
DRUG: Furosemide
DRUG: Isotonic saline
Conditions
- Fluid Overload
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Research sites nearby
Closest Location:
Department of Intensive Care, Liverpool Hospital
Select from list below to view details:
Department of Intensive Care, Liverpool Hospital
Sydney, Australia
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Who is running the clinical trial?
Morten H. Bestle
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Furosemide
| Drug: Furosemide |
PLACEBO_COMPARATOR: Placebo
| Drug: Isotonic saline |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Days alive and out of hospital | Days alive and out of hospital | 90 days after randomization |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | All cause mortality | 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) | 90 days after randomization |
| Mortality 1 year | All cause mortality | one year after randomization |
| Serious adverse events and reactions | Number of participants with one or more serious adverse events and serious adverse reactions | 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. | 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. | 1 year after randomization |
| Health related quality of life | Subjective assessment (unacceptable, neutral, acceptable) | 1 year after randomization |
References
Clinical Trials Gov: Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.Other trials to consider
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