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

  • STATUS
    Recruiting
  • End date
    Jun 17, 2025
  • participants needed
    1000
  • sponsor
    Morten H. Bestle
Updated on 26 May 2022
edema
furosemide
norepinephrine

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.

Details
Condition Fluid Overload
Treatment Furosemide, Isotonic saline
Clinical Study IdentifierNCT04180397
SponsorMorten H. Bestle
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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
Ongoing life-threatening bleeding as these patients need specific fluid/blood product strategies
Rhabdomyolysis with indication for forced diuresis
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note