Fluid removal treatment for critically ill patients with fluid overload
Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).
This study is testing if a medication called furosemide can safely help critically ill patients in the ICU get rid of extra fluid in their bodies compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nordsjaellands Hospital Academic / other |
| Locations | 24 sites (Sydney and 23 other locations) |
| Trial ID | NCT04180397 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of goal-directed fluid removal using furosemide compared to a placebo in critically ill adult patients experiencing fluid overload in the intensive care unit (ICU). Patients will be randomly assigned to receive either furosemide or a placebo until the excess fluid is excreted. The study aims to determine whether fluid overload is causally linked to adverse outcomes or merely a marker of disease severity. The inclusion criteria require patients to be clinically stable and have a fluid overload of 5% or more of their ideal body weight.
Who should consider this trial
Good fit: Ideal candidates are critically ill adults aged 18 or older with a fluid overload of 5% or more of their ideal body weight.
Not a fit: Patients with advanced chronic kidney disease, ongoing renal replacement therapy, or severe dysnatremia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for critically ill patients suffering from fluid overload.
How similar studies have performed: Previous observational studies have indicated potential benefits of fluid removal in similar patient populations, but this approach is being rigorously tested in a controlled setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sydney and 23 other locations
- Department of Intensive Care, Liverpool Hospital — Sydney, Australia (Not_yet_recruiting)
- Department of Intensive Care, Sygehus Sønderjylland Aabenraa — Aabenraa, Denmark (Recruiting)
- Departmen of Intensive Care — Aalborg, Denmark (Recruiting)
- Department of Intensive Care, Aarhus University Hospital — Aarhus, Denmark (Terminated)
- Department of Intensive Care, Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Departement of Intensive Care, Gentofte Hospital — Gentofte Municipality, Denmark (Terminated)
- Department of Intensive Care, Herlev Hospital — Herlev, Denmark (Recruiting)
- Department of Intensive Care, Regionshospital Gødstrup — Herning, Denmark (Recruiting)
- Department of Intensive Care, Nordsjællands hospital — Hillerød, Denmark (Recruiting)
- Department of Intensive Care, Regionshospital Nordjylland Hjørring — Hjørring, Denmark (Recruiting)
- Department of Intensive Care — Kolding, Denmark (Recruiting)
- Department of Intensive Care, Zealand University hospital — Køge, Denmark (Recruiting)
- Department of Intensive Care — Odense, Denmark (Recruiting)
- Department of Intensive Care, Regionshospitalet Randers — Randers, Denmark (Recruiting)
- Department of Intensive Care, University Hospital Zealand, Roskilde — Roskilde, Denmark (Recruiting)
- Department of Intensive Care — Vejle, Denmark (Withdrawn)
- Regionshospitalet Viborg — Viborg, Denmark (Recruiting)
- Department of Intensive Care, Tampere University Hospital — Tampere, Finland (Terminated)
- Department of Intensive Care — Turku, Finland (Terminated)
- Department of Intensive Care, Landspitali National University Hospital of Iceland — Reykjavik, Iceland (Terminated)
- Department of Critical Care, University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Department of Intensive Care, Ålesund Sjukehus — Ålesund, Norway (Terminated)
- Department of Intensive Care, Stavanger University Hospital — Stavanger, Norway (Terminated)
- Department of Intensive Care, Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Sine Wichmann, MD
- Email: sine.wichmann@regionh.dk
- Phone: +45 26142620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.