Goal directed fluid removal with furosemide in intensive care patients with fluid overload - A randomised, blinded, placebo-controlled trial

Phase 4

Recruiting

Conditions: vochtoverbelasting bij acute opgenomen intensive care patiënten
acute admitted intensive care patients
fluid overload

Registration Number: NL-OMON52060

Lead Sponsor: ordsjaellands Hospital, University of Copenhagen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

All of the following criteria must be fulfilled:
• Acute admission to the Intensive Care Unit.
• Age >= 18 years of age.
• Fluid overload defined as a positive cumulative fluid balance (according to
the daily fluid charts) corresponding >= 5 % of ideal body weight (calculated
as: 22 x (height in meters)^2). If possible, all fluids administered before
admission to the ICU are to be included in the calculation of cumulative fluid
balance.
• Clinical stable defined as Mean Arterial Pressure > 50 mmHg and maximum
infusion of 0.20 microgram/kg/minute of noradrenaline and lactate < 4.0 mmol/L.

Exclusion Criteria

• Known allergy to furosemide or sulphonamides.
• Known pre-hospitalisation advanced chronic kidney disease (eGFR < 30
mL/minute/1.73 m2 or chronic RRT).
• Ongoing RRT.
• Anuria for >= 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 dysnatraemia (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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is days alive and out of hospital at day 90.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are days alive at day 90 without life support, all-cause<br /><br>mortality at day 90, and all-cause mortality 1 year after randomisation, and<br /><br>serious adverse events and reactions in the ICU</p><br>