NCT04180397

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Morten H. Bestle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Fluid Overload

Interventions

Type	Name	Description
DRUG	Furosemide	Furosemide 10 mg/ml for injection/infusion
DRUG	Isotonic saline	Isotonic saline used as placebo (injection/infusion)

Timeline

• Start date: 2020-08-17
• Primary completion: 2026-12-31
• Completion: 2028-03-15
• First posted: 2019-11-27
• Last updated: 2025-02-06

Locations

24 sites across 7 countries: Australia, Denmark, Finland, Iceland, Netherlands, Norway, Switzerland