Health TrialsbyHealthPanel

Bumetanide vs. Furosemide in Cirrhosis

ConditionCirrhosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStacy Johnson

About this trial

Patients with cirrhosis are frequently hospitalized due to an acute decompensation of their liver disease including bleeding, jaundice, encephalopathy, and volume overload. Volume overload is associated with increased mortality from acute hypoxic respiratory failure, hemorrhage from esophageal varices, and spontaneous bacterial peritonitis.

Clinical practice guidelines describe sodium restriction and diuretics as first-line treatment, combined with regular body weight monitoring to assess response. In patients with suboptimal response to furosemide, alternative loop diuretics like torsemide or bumetanide may improve natriuresis. Bumetanide has a theoretic advantage over furosemide due to its more rapid and complete intestinal absorption, combined with a prolonged half-life in patients with hepatic dysfunction. In this pragmatic study, the aim is to compare the efficacy of diuresis with bumetanide versus furosemide among hospitalized patients with cirrhosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of liver cirrhosis

Clinician placed an order for bumetanide or furosemide in electronic health record within 24 hours of presentation to the hospital

Disqualifiers

Allergy to bumetanide or furosemide

Contraindication to diuretic administration (e.g. active bleeding, clinical suspicion of hepatorenal syndrome, hypotension)

Incarcerated or in custody of law enforcement

Diuretic ordered for purpose other than volume overload (e.g. hyperkalemia, continuation of home medication without clinical signs of volume overload)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bumetanide

    Drug

    Standard of care treatment with bumetanide (intravenous or oral administration) per treating clinician's orders

  • Furosemide

    Drug

    Standard of care treatment with furosemide (intravenous or oral administration) per treating clinician's orders

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: BumetanideExperimental treatment 1 intervention
Group B: FurosemideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in weight

Percent change in weight measured in kilograms from date of emergency department presentation (Day 0) to Day 7 of hospitalization, or date of discharge, whichever is earlier

Time frame
7 days

Secondary outcomes

1

Development of acute kidney injury

Stage 2 or higher acute kidney injury developing within 14 days of presentation to emergency department in accordance with KDIGO criteria

Time frame
14 days
2

Need for replacement therapy

New initiation of intermittent or continuous hemodialysis within 14 days of presentation to the emergency department

Time frame
14 days
3

Severe electrolyte derangement

New decrease in serum potassium to less than 2.5 mEq/L within 14 days of presentation to the emergency department

Time frame
14 days
4

Hospital length of stay

Time from initial presentation to the emergency department to the time of discharge from the hospital or time of death, if a subject dies within the hospital

Time frame
30 days

Other outcomes

Sponsors and contacts

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

Stacy Johnson

Lead sponsor

University of Utah

Sponsor institution

Source ClinicalTrials.gov
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