Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2028-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Forced Fluid Removal in High Risk Acute Kidney Injury

NCT02458157

Acute Kidney Injury Fluid Overload Critical Illness

TERMINATED PHASE4

Furosemide Stress Test to Predict Successful Liberation From RRT

NCT05612490

Acute Kidney Injury

COMPLETED

Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients

NCT00298454

Renal Failure Critically Ill

TERMINATED PHASE3

Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

NCT05401812

Acute Respiratory Distress Syndrome

WITHDRAWN PHASE2

The Furosemide Stress Test, Electrolytes Response and Renal Index in Critically Ill Patients

NCT04215419

Acute Kidney Injury

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fluid Overload

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Furosemide

Bolus of 5-40 mg (0.5 - 4 ml) of furosemide iv at physicians discretion followed by infusion of furosemide. Infusion rate: 0-40 mg/hour. Starting rate: 20 mg/hour. The infusion is adjusted according effect. Target is a negative fluid balance of 1 ml/kg/hour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral.

Group Type ACTIVE_COMPARATOR

Furosemide

Intervention Type DRUG

Furosemide 10 mg/ml for injection/infusion

Placebo

Isotonic saline dosed the same way and by the same algorithm as for furosemide. Start bolus of 0.5-4 ml at physicians discretion. Infusion rate: 0 - 4 ml/hour. Infusion is started at 2 ml/hour and adjusted according to effect. Target is a negative fluid balance of 1 ml/kg/hour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral.

Group Type PLACEBO_COMPARATOR

Isotonic saline

Intervention Type DRUG

Isotonic saline used as placebo (injection/infusion)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Furosemide

Furosemide 10 mg/ml for injection/infusion

Intervention Type DRUG

Isotonic saline

Isotonic saline used as placebo (injection/infusion)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Furix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No