Fluid removal treatment for critically ill patients with fluid overload

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Intensive Care, Liverpool Hospital
  Sydney, Australia Recruiting
• Department of Intensive Care, Royal North Shore Hospital
  Sydney, Australia Recruiting
• Department of Intensive Care, University Hospital of Pilsen
  Pilsen, Czechia Recruiting
• Department of Intensive Care, IKEM
  Prague, Czechia Recruiting
• Departmen of Intensive Care
  Aalborg, Denmark Recruiting
• Department of Intensive Care, Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Study coordinator: Sine Wichmann, MD
• Email: sine.wichmann@regionh.dk
• Phone: +45 26142620

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a bioimpedance device to track fluid status in children after stem cell transplant

  The study tests whether bedside bioimpedance measurements can reliably track body water changes in children undergoing stem cell transplantation, alongside standard fluid checks.

  Recruiting St. Jude Children's Research Hospital · Memphis, Tennessee · NCT07834710

• Personalized High-Rate Fluid Removal Guided by Ultrasound in Hospitalized ESRD with Fluid Overload

  This trial tests whether using ultrasound to guide a higher rate of fluid removal is as safe and effective as standard fluid removal for adults with end-stage kidney disease who are admitted for severe fluid overload.

  Recruiting Universidad Autonoma de Nuevo Leon · Monterrey, Nuevo León · NCT07705269

• Understanding how patients tolerate fluid removal during kidney support in the ICU

  This observational study tests how well critically ill adults with acute kidney injury tolerate net fluid removal during continuous renal replacement therapy.

  Recruiting at 3 sites Hospital Las Higueras · Salvador and 9 other locations · NCT07643597

• Electric cardiometry-guided fluid therapy during robotic prostatectomy

  This study tests whether using an electrical cardiometry device to guide fluid administration during robotic prostatectomy improves patient care compared with a standard fluid approach.

  Recruiting Cairo University · Cairo · NCT07626151

• When and how much fluid to remove in critically ill patients

  This study will test which patients, timing, and rates of fluid removal (diuretics or ultrafiltration) work best for critically ill adults in the ICU who need deresuscitation.

  Recruiting at 2 sites Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam and 1 other locations · NCT07275658

• AI-guided blood-pressure and fluid management during cytoreductive surgery with HIPEC

  This trial will test whether an AI-based hemodynamic monitoring protocol during cytoreductive surgery with HIPEC helps adults with ovarian cancer avoid low blood pressure and fluid overload.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome · NCT07070973

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.