Authorised Therapeutic use (Phase IV) Fluid overload/fluid accumulation

Goal directed fluid removal in critically ill patients with fluid overload

EU CTIS ID: 2024-512186-14-00

What this study is testing

To assess the benefits and harms of goal-directed fluid removal with furosemide versus placebo on patient-important outcome measures in adult ICU patients with moderate to severe fluid overload. The primary objective is to determine if forced fluid removal with furosemide compared with placebo (spontaneous fluid excretion) will increase the number of days alive and out of hospital at day 90 day

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • All the following parameters must be met: acute admission to the ICU, 18 years of age or above, clinically stable assessed by the clinicians (minimum criteria: MAP > 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate < 4.0 mmol/l), and fluid accumulation estimated according to daily fluid balance, the cumulative fluid balance, development in body weight, and clinical examination corresponding to at least 5% of ideal body wight

You likely can't join if

  • Known allergy to furosemide or sulphonamides; known pre-hospitalisation advanced chronic kidney disease (eGFR < 30 mL/minute/1.73 m2 or chronic renal replacement therapy); ongoing renal replacement therapy; anuria for ≥ 6 hours; rhabdomyolysis with indication for forced diuresis; ongoing life-threatening bleeding; acute burn injury of more than 10 % of the body surface area, severe dysnatraemia (p-Na < 120 or > 155 mmol/l); severe hepatic failure; patients undergoing compulsory 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

  • Switzerland
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Switzerland; Australia. 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 EU CTIS; the study team decides eligibility.