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Bumetanide vs. Furosemide in Cirrhosis (BUFF)

S

Stacy Johnson

Status and phase

Begins enrollment in 1 month
Phase 3

Conditions

Cirrhosis

Treatments

Drug: Bumetanide
Drug: Furosemide

Study type

Interventional

Funder types

Other

Identifiers

NCT06941415
IRB_00186841

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

Bumetanide
Experimental group
Treatment:
Drug: Bumetanide
Furosemide
Experimental group
Treatment:
Drug: Furosemide

Trial contacts and locations

1

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Central trial contact

Andrea T White, PhD

Data sourced from clinicaltrials.gov

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