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Bumetanide vs. Furosemide in Cirrhosis

Phase 3
Not yet recruiting
Conditions
Cirrhosis
Interventions
Registration Number
NCT06941415
Lead Sponsor
Stacy Johnson
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
500
Inclusion Criteria
  • History of liver cirrhosis
  • Clinician placed an order for bumetanide or furosemide in electronic health record within 24 hours of presentation to the hospital
Exclusion Criteria
  • 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)
  • Inpatient admission not anticipated
  • Not admitted to an inpatient hospital bed following initial evaluation in the emergency department

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BumetanideBumetanide-
FurosemideFurosemide-
Primary Outcome Measures
NameTimeMethod
Percent change in weight7 days

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

Secondary Outcome Measures
NameTimeMethod
Development of acute kidney injury14 days

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

Need for replacement therapy14 days

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

Severe electrolyte derangement14 days

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

Hospital length of stay30 days

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

Unplanned hospital readmission30 days

Readmission to the hospital for an unexpected reason within 30 days of a prior hospital admission

30-day mortality30 days

Death occurring within the 30 days following presentation to the emergency department and subsequent hospital admission

Trial Locations

Locations (1)

University of Utah Hospital

🇺🇸

Salt Lake City, Utah, United States

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