Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.

Last updated: February 5, 2025
Sponsor: Morten H. Bestle
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Furosemide

Isotonic saline

Clinical Study ID

NCT04180397
GODIF
  • Ages > 18
  • All Genders

Study Summary

This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.

Eligibility Criteria

Inclusion

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 administeredbefore admission to the intensive care unit are to be included in the calculation ofcumulative fluid balance.

  • Clinical stable (minimum criteria: MAP > 50 mmHg and maximum infusion of 20microgram/kg/minute of noradrenaline and lactate < 4.0 mmol/L)

Exclusion

Exclusion Criteria:

  • Known allergy to furosemide or sulphonamides.

  • Known pre-hospitalization advanced chronic kidney disease (eGFR < 30 mL/minute/1.73m^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/bloodproduct strategies.

  • Acute burn injury of more than 10% of the body surface area as these patients need aspecific fluid strategy.

  • Severe dysnatremia (p-Na < 120 or > 155 mmol/L) as these patients need a specificfluid 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

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Furosemide
Phase: 4
Study Start date:
August 17, 2020
Estimated Completion Date:
March 15, 2028

Study Description

Fluid overload is a common and serious complication in patients admitted to the intensive care unit (ICU). A core element of therapy in the ICU is resuscitation with crystalloid solutions. In many cases fluid accumulate, and patients become fluid overloaded. Several observational studies indicate a detrimental effect of fluid overload in different clinical settings, including patients with acute kidney injury. It is unknown whether this association is causal or if the increased tendency to accumulate fluid is a marker of disease severity and thereby a higher risk of death. The investigators want to investigate this in critical ill patients with fluid overload of 5% or more by randomizing them to furosemide (diuretics) or placebo.

Connect with a study center

  • Department of Intensive Care, Liverpool Hospital

    Sidney,
    Australia

    Site Not Available

  • Department of Intensive Care, Sygehus Sønderjylland Aabenraa

    Aabenraa,
    Denmark

    Active - Recruiting

  • Departmen of Intensive Care

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Department of Intensive Care, Aarhus University Hospital

    Aarhus,
    Denmark

    Terminated

  • Dorte Illum

    Aarhus,
    Denmark

    Terminated

  • Department of Intensive Care, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Departement of Intensive Care, Gentofte Hospital

    Gentofte,
    Denmark

    Terminated

  • Department of Intensive Care

    Hellerup, 2900
    Denmark

    Site Not Available

  • Department of Intensive Care, Herlev Hospital

    Herlev, 2730
    Denmark

    Active - Recruiting

  • Department of Intensive Care, Regionshospital Gødstrup

    Herning, 7400
    Denmark

    Active - Recruiting

  • Department of Intensive Care, Nordsjællands hospital

    Hillerød, 3400
    Denmark

    Active - Recruiting

  • Department of Intensive Care, Regionshospital Nordjylland Hjørring

    Hjørring,
    Denmark

    Active - Recruiting

  • Department of Intensive Care

    Kolding, 6000
    Denmark

    Active - Recruiting

  • Department of Intensive Care, Zealand University hospital

    Køge, 4600
    Denmark

    Active - Recruiting

  • Department of Intensive Care

    Odense, 5000
    Denmark

    Active - Recruiting

  • Department of Intensive Care, Regionshospitalet Randers

    Randers, 8930
    Denmark

    Active - Recruiting

  • Department of Intensive Care, University Hospital Zealand, Roskilde

    Roskilde,
    Denmark

    Active - Recruiting

  • Department of Intensive Care

    Vejle, 7100
    Denmark

    Site Not Available

  • Department of Intensive Care

    Viborg, 8800
    Denmark

    Site Not Available

  • Regionshospitalet Viborg

    Viborg, 8800
    Denmark

    Active - Recruiting

  • Department of Intensive Care, Tampere University Hospital

    Tampere, 33520
    Finland

    Terminated

  • Department of Intensive Care

    Turku,
    Finland

    Terminated

  • Department of Intensive Care, Landspitali National University Hospital of Iceland

    Reykjavík,
    Iceland

    Terminated

  • Department of Critical Care, University Medical Center Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Department of Intensive Care, Stavanger University Hospital

    Stavanger, 4068
    Norway

    Terminated

  • Department of Intensive Care, Ålesund Sjukehus

    Ålesund,
    Norway

    Terminated

  • Department of Intensive Care, Inselspital

    Bern,
    Switzerland

    Active - Recruiting

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