NCT04180397 Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
| NCT ID | NCT04180397 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Morten H. Bestle |
| Condition | Fluid Overload |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2020-08-17 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,000 participants in total. It began in 2020-08-17 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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) 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.
Contact & Investigator
Morten Bestle, MD
STUDY CHAIR
Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital
Frequently Asked Questions
Who can join the NCT04180397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fluid Overload. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04180397 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04180397 currently recruiting?
Yes, NCT04180397 is actively recruiting participants. Contact the research team at sine.wichmann@regionh.dk for enrollment information.
Where is the NCT04180397 trial being conducted?
This trial is being conducted at Sydney, Australia, Sydney, Australia, Ostrava, Czechia, Pilsen, Czechia and 11 additional locations.
Who is sponsoring the NCT04180397 clinical trial?
NCT04180397 is sponsored by Morten H. Bestle. The principal investigator is Morten Bestle, MD at Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital. The trial plans to enroll 1,000 participants.