Bumetanide vs. Furosemide for Liver Cirrhosis

(BUFF Trial)

Overseen By Andrea T White, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stacy Johnson

Must be taking: Bumetanide, Furosemide

Disqualifiers: Allergy, Contraindication, Incarcerated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it involves switching to either bumetanide or furosemide for treating volume overload in liver cirrhosis. It's best to discuss with your doctor about any changes to your medication.

Is bumetanide or furosemide safe for treating liver cirrhosis?

Both bumetanide and furosemide are generally safe when used within recommended doses, but they can cause side effects like electrolyte imbalances (changes in blood minerals) and, in some cases, more severe reactions in people with liver cirrhosis. Bumetanide may have fewer hearing-related side effects compared to furosemide. ^{1 2 3 4 5}

How do bumetanide and furosemide differ in treating liver cirrhosis?

Bumetanide and furosemide are both diuretics used to treat fluid retention in liver cirrhosis, but bumetanide is about 40 times more potent on a milligram-for-milligram basis. Bumetanide has a longer duration of action (12 hours) compared to furosemide (6 hours), although this difference is not clinically significant. Both drugs have similar side effects, but bumetanide may be preferred in patients at higher risk of hearing damage (ototoxicity). ^{2 4 5 6 7}

What is the purpose of this 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.

Research Team

Stacy A Johnson, MD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for hospitalized patients with cirrhosis, a condition where the liver becomes scarred. They should be experiencing complications like fluid overload and have not responded well to standard diuretics. There are no specific exclusion criteria provided, but typically those with other serious health issues or allergies to the drugs would not qualify.

Inclusion Criteria

I have a history of liver cirrhosis.

My doctor prescribed bumetanide or furosemide within 24 hours of my hospital visit.

Exclusion Criteria

Inpatient admission not anticipated

Allergy to bumetanide or furosemide

Incarcerated or in custody of law enforcement

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either bumetanide or furosemide to compare the efficacy of diuresis among hospitalized patients with cirrhosis

7 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of weight change and kidney function

30 days

Treatment Details

Interventions

• Bumetanide
• Furosemide

Trial Overview The study is testing two diuretic medications: Bumetanide and Furosemide. These drugs help remove excess fluid from the body in patients whose livers can't do it naturally due to cirrhosis. The goal is to see which drug works better for these patients.

Participant Groups

Group I: Furosemide Experimental Treatment 1 Intervention

Group II: Bumetanide Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stacy Johnson

Lead Sponsor

Findings from Research

In a four-year study of 533 hospitalized patients receiving furosemide, 39.8% experienced adverse reactions (ARs), with the most common being electrolyte disturbances and extracellular volume depletion, indicating a significant incidence of ARs associated with this medication.

While the overall frequency of severe ARs was low, they were notably higher in patients with liver cirrhosis, suggesting that these patients require careful monitoring when treated with furosemide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Furosemide-induced adverse reactions during hospitalization. Naranjo, CA., Busto, U., Cassis, L.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of adverse reactions to bumetanide and furosemide. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of fluid retention in cirrhosis: a comparison of bumetanide and frusemide. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Furosemide-induced adverse reactions during hospitalization. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Bumetanide: a new loop diuretic (Bumex, Roche Laboratories). [2019]

5. England pubmed.ncbi.nlm.nih.gov

Use of bumetanide in the treatment of ascites due to liver disease. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Bumetanide in refractory ascites of cirrhosis of the liver: a comparison with furosemide. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A comparison of bumetanide and furosemide in the treatment of ascites. Cooperative study. [2019]