Bumetanide vs. Furosemide in Cirrhosis

NCT06941415 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IRB_00186841
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Keywords

cirrhosis; volume overload; diuresis; furosemide; bumetanide

Outcome Measures

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

  7 days

Secondary Outcomes (6)

• Development of acute kidney injury

  14 days

• Need for replacement therapy

  14 days

• Severe electrolyte derangement

  14 days

• Hospital length of stay

  30 days

• Unplanned hospital readmission

  30 days

Study Arms (2)

Bumetanide

EXPERIMENTAL

Drug: Bumetanide

Furosemide

EXPERIMENTAL

Drug: Furosemide

Interventions

Bumetanide DRUG

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

Bumetanide

Furosemide DRUG

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

Furosemide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stacy Johnson: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Fibrosis; Edema

Interventions

Bumetanide; Furosemide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Sulfanilamides; Aniline Compounds; Amines

Study Officials

• Stacy A Johnson, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea T White, PhD

CONTACT

8015817818; andrea.white@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Following publication of manuscript
• Access Criteria: Written request and local institutional approval

Locations

US (1)