CirrhosisPhase 3BUFFNCT06941415
Bumetanide vs. Furosemide in Cirrhosis
A Phase 3 study testing Bumetanide and Furosemide in people with Cirrhosis, run by Stacy Johnson at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Bumetanide and Furosemide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to 31 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of liver cirrhosis
- Clinician placed an order for bumetanide or furosemide in electronic health record within 24 hours of presentation to the hospital
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Andrea T White, PhD, 801-581-7818, andrea.white@hsc.utah.edu
Stacy A Johnson, MD
About this study
Official title: 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.
- Conditions
- Cirrhosis
- Being tested
- Bumetanide, Furosemide
- Keywords
- cirrhosis, volume overload, diuresis, furosemide, bumetanide
- Medical subject headings
- Fibrosis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BumetanideDrug
Standard of care treatment with bumetanide (intravenous or oral administration) per treating clinician's orders
FurosemideDrug
Standard of care treatment with furosemide (intravenous or oral administration) per treating clinician's orders
| Study group | Role | What they receive |
|---|---|---|
| Bumetanide | Experimental | Not described Receives: Drug: Bumetanide |
| Furosemide | Experimental | Not described Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (6)
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
Measured: 14 days
Need for replacement therapy
New initiation of intermittent or continuous hemodialysis within 14 days of presentation to the emergency department
Measured: 14 days
Severe electrolyte derangement
New decrease in serum potassium to less than 2.5 mEq/L within 14 days of presentation to the emergency department
Measured: 14 days
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
Measured: 30 days
Unplanned hospital readmission
Readmission to the hospital for an unexpected reason within 30 days of a prior hospital admission
Measured: 30 days
30-day mortality
Death occurring within the 30 days following presentation to the emergency department and subsequent hospital admission
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start3 Jun 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stacy Johnson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stacy Johnson, University of Utah
- Investigators
- Stacy A Johnson, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941415
- Sponsor's protocol ID
- IRB_00186841
- Acronym
- BUFF
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Findings from the study will be presented at one or more scientific conferences. Results will be submitted for publication to a peer-reviewed journal. Data will be made available to other researchers after publication upon request and local institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bumetanide vs. Furosemide for Adults Hospitalized With Cirrhosis: the BUFF Trial
- ClinicalTrials.gov ID
- NCT06941415
- Acronym / sponsor ID
- BUFF / IRB_00186841
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, volume overload, diuresis, furosemide, bumetanide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Stacy JohnsonUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bumetanide | Experimental | Drug: Bumetanide |
| Furosemide | Experimental | Drug: Furosemide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of liver cirrhosis
- Clinician placed an order for bumetanide or furosemide in electronic health record within 24 hours of presentation to the hospital
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BumetanideStandard of care treatment with bumetanide (intravenous or oral administration) per treating clinician's orders | Drug | Bumetanide |
| FurosemideStandard of care treatment with furosemide (intravenous or oral administration) per treating clinician's orders | Drug | Furosemide |
Primary outcome
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
6 secondary outcomes
Development of acute kidney injury
Time frame: 14 days
Need for replacement therapy
Time frame: 14 days
Severe electrolyte derangement
Time frame: 14 days
Hospital length of stay
Time frame: 30 days
Unplanned hospital readmission
Time frame: 30 days
30-day mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. Findings from the study will be presented at one or more scientific conferences. Results will be submitted for publication to a peer-reviewed journal. Data will be made available to other researchers after publication upon request and local institutional approval.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacy A Johnson, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bumetanide and Furosemide in people with Cirrhosis, run by Stacy Johnson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea T White, PhD (8015817818, andrea.white@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in weight (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.