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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52060

Enrollment

100

Registered

2023-02-09

Start date

2023-08-30

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention: The experimental intervention is goal directed fluid removal aimed at neutral fluid balance achieved as fast as possible and maintained throughout the entire ICU stay. Neutral fluid ba

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: • Known allergy to furosemide or sulphonamides. • Known pre-hospitalisation advanced chronic kidney disease (eGFR = 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 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

Design outcomes

Primary

Measure	Time frame
The primary outcome is days alive and out of hospital at day 90.	—

Secondary

Measure	Time frame
Secondary outcomes are days alive at day 90 without life support, all-cause mortality at day 90, and all-cause mortality 1 year after randomisation, and serious adverse events and reactions in the ICU	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)