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NCT Number: NCT04180397

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Intensive Care, Liverpool Hospital, Sydney, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Furosemide

Drug

Furosemide 10 mg/ml for injection/infusion

Other names: Furix

Isotonic saline

Drug

Isotonic saline used as placebo (injection/infusion)

Primary outcomes

  1. Days alive and out of hospital

    Time frame: 90 days after randomization

    Days alive and out of hospital

Secondary outcomes

  1. All cause mortality

    Time frame: 90 days after randomization

    All cause mortality

  2. Mortality and life support

    Time frame: 90 days after randomization

    Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy)

  3. Mortality 1 year

    Time frame: one year after randomization

    All cause mortality

  4. Serious adverse events and reactions

    Time frame: 90 days

    Number of participants with one or more serious adverse events and serious adverse reactions

  5. Health related quality of life

    Time frame: 1 year after randomization

    Measured using the European quality of Life 5D-5L questionnaire (5D-5L is the full name of the questionnaire). Index value of 1 represents full health and dead = 0. These value sets reflect the preferences of the general population. The European quality of life visual analogue scale is a self-reported assessment of the participant's health status. Scores on 100 = the best health you can imagine and 0 = the worst health you can imagine.

  6. Cognitive function

    Time frame: 1 year after randomization

    Cognitive function assessed by the Montreal Cognitive Assessment score. Using the mini test for telephone interview. The test and scoring system will soon be published from Montreal Cognitive Assessment.

  7. Health related quality of life

    Time frame: 1 year after randomization

    Subjective assessment (unacceptable, neutral, acceptable)

Study contacts

Contact information is provided by the study sponsor or research team.

Morten Bestle, MD

CONTACT

[email protected]

+45 41951195

Sine Wichmann, MD

CONTACT

[email protected]

+45 26142620

Sponsors and collaborators

Lead sponsor

Morten H. Bestle

Other

Collaborators

  • Centre for Research in Intensive Care (CRIC)
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • University of Copenhagen

Registry information

Official study title

Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).

Acronym: GODIF

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Nov 27, 2019
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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