Health Trials

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

ConditionFluid Overload
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMorten H. Bestle

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Known allergy to furosemide or sulphonamides.

Known pre-hospitalization advanced chronic kidney disease (eGFR < 30 mL/minute/1.73 m² or chronic RRT).

Ongoing renal replacement therapy.

Anuria > 6 hours.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Furosemide

    Drug

    Furosemide 10 mg/ml for injection/infusion

  • Isotonic saline

    Drug

    Isotonic saline used as placebo (injection/infusion)

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: FurosemideActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Days alive and out of hospital

Days alive and out of hospital

Time frame
90 days after randomization

Secondary outcomes

1

All cause mortality

All cause mortality

Time frame
90 days after randomization
2

Mortality and life support

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

Time frame
90 days after randomization
3

Mortality 1 year

All cause mortality

Time frame
one year after randomization
4

Serious adverse events and reactions

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

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Morten H. Bestle

Lead sponsor

Nordsjaellands Hospital

Sponsor institution

University of Copenhagen

Collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

Collaborator

Centre for Research in Intensive Care (CRIC)

Collaborator

Source ClinicalTrials.gov
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