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New treatment option for Fluid Overload
Official title Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
ClinicalTrials.gov ID: NCT04180397
What this study is testing
What is Furosemide?
Furosemide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for fluid overload.
Also referred to as Furix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Clinical stable (minimum criteria: MAP \> 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate \< 4.0 mmol/L)
You likely can't join if
- 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.
See the full eligibility 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)
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, Australia
- Ostrava, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Aabenraa, Denmark
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Gentofte Municipality, Denmark
- Herlev, Denmark
- Herning, Denmark
- Hillerød, Denmark
- Hjørring, Denmark
- Kolding, Denmark
- Køge, Denmark
- Odense, Denmark
- Randers, Denmark
- Roskilde, Denmark
- Vejle, Denmark
- Viborg, Denmark
+ 8 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, Australia; Ostrava, Czechia; Pilsen, Czechia; Prague, Czechia; Aabenraa, Denmark; Aalborg, Denmark and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.