- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06941415
Bumetanide vs. Furosemide in Cirrhosis (BUFF)
Bumetanide vs. Furosemide for Adults Hospitalized With Cirrhosis: the BUFF 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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Andrea T White, PhD
- Phone Number: 8015817818
- Email: andrea.white@hsc.utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- Recruiting
- University of Utah Hospital
-
Contact:
- Andrea T White, PhD
- Phone Number: 801-581-7818
- Email: andrea.white@hsc.utah.edu
-
Principal Investigator:
- Stacy A Johnson, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bumetanide
|
Standard of care treatment with bumetanide (intravenous or oral administration) per treating clinician's orders
|
|
Experimental: Furosemide
|
Standard of care treatment with furosemide (intravenous or oral administration) per treating clinician's orders
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent change in weight
Time Frame: 7 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
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of acute kidney injury
Time Frame: 14 days
|
Stage 2 or higher acute kidney injury developing within 14 days of presentation to emergency department in accordance with KDIGO criteria
|
14 days
|
|
Need for replacement therapy
Time Frame: 14 days
|
New initiation of intermittent or continuous hemodialysis within 14 days of presentation to the emergency department
|
14 days
|
|
Severe electrolyte derangement
Time Frame: 14 days
|
New decrease in serum potassium to less than 2.5 mEq/L within 14 days of presentation to the emergency department
|
14 days
|
|
Hospital length of stay
Time Frame: 30 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
|
30 days
|
|
Unplanned hospital readmission
Time Frame: 30 days
|
Readmission to the hospital for an unexpected reason within 30 days of a prior hospital admission
|
30 days
|
|
30-day mortality
Time Frame: 30 days
|
Death occurring within the 30 days following presentation to the emergency department and subsequent hospital admission
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stacy A Johnson, MD, University of Utah
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Fibrosis
- Edema
- Sulfur Compounds
- Organic Chemicals
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carboxylic Acids
- Hydrocarbons, Aromatic
- Amides
- Aniline Compounds
- Amines
- Benzene Derivatives
- Acids, Carbocyclic
- Sulfonamides
- Sulfanilamides
- Sulfones
- Aminobenzoates
- Benzoates
- meta-Aminobenzoates
- Furosemide
- Bumetanide
Other Study ID Numbers
- IRB_00186841
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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