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

Fluid Overload Clinical Trial

— GODIF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180397
• Other study ID #: GODIF
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2020
• Est. completion date: June 17, 2025

Study information

• Verified date: September 2023
• Source: Nordsjaellands Hospital
• Contact: Sine Wichmann, MD
• Phone: +45 26142620
• Email: sine.wichmann[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 17, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Overload

Intervention

Drug:
• Furosemide
Furosemide 10 mg/ml for injection/infusion
• Isotonic saline
Isotonic saline used as placebo (injection/infusion)

Locations

Country	Name	City	State
Denmark	Department of Intensive Care, Sygehus Sønderjylland Aabenraa	Aabenraa
Denmark	Departmen of Intensive Care	Aalborg
Denmark	Dorte Illum	Aarhus
Denmark	Department of Intensive Care, Rigshospitalet	Copenhagen
Denmark	Departement of Intensive Care, Gentofte Hospital	Gentofte
Denmark	Department of Intensive Care, Herlev Hospital	Herlev
Denmark	Department of Intensive Care, Regionshospital Gødstrup	Herning
Denmark	Department of Intensive Care, Nordsjællands hospital	Hillerød
Denmark	Department of Intensive Care, Regionshospital Nordjylland Hjørring	Hjørring
Denmark	Department of Intensive Care, Zealand University hospital	Køge
Denmark	Department of Intensive Care	Kolding
Denmark	Department of Intensive Care	Odense
Denmark	Department of Intensive Care, Regionshospitalet Randers	Randers
Denmark	Department of Intensive Care, University Hospital Zealand, Roskilde	Roskilde
Denmark	Department of Intensive Care	Vejle
Denmark	Regionshospitalet Viborg	Viborg
Finland	Department of Intensive Care, Tampere University Hospital	Tampere
Finland	Department of Intensive Care	Turku
Iceland	Department of Intensive Care, Landspitali National University Hospital of Iceland	Reykjavík
Netherlands	Department of Critical Care, University Medical Center Groningen	Groningen
Norway	Department of Intensive Care, Ålesund Sjukehus	Ålesund
Norway	Department of Intensive Care, Stavanger University Hospital	Stavanger
Switzerland	Department of Intensive Care, Inselspital	Bern

Sponsors (4)

Lead Sponsor	Collaborator
Morten H. Bestle	Centre for Research in Intensive Care (CRIC), Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen

Countries where clinical trial is conducted

Denmark,  Finland,  Iceland,  Netherlands,  Norway,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days alive and out of hospital	Days alive and out of hospital	90 days after randomization
Secondary	All cause mortality	All cause mortality	90 days after randomization
Secondary	Mortality and life support	Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy)	90 days after randomization
Secondary	Mortality 1 year	All cause mortality	one year after randomization
Secondary	Serious adverse events and reactions	Number of participants with one or more serious adverse events and serious adverse reactions	90 days
Secondary	Health related quality of life	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.	1 year after randomization
Secondary	Cognitive function	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.	1 year after randomization
Secondary	Health related quality of life	Subjective assessment (unacceptable, neutral, acceptable)	1 year after randomization