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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two medications, bumetanide and furosemide, assist people with liver cirrhosis in managing fluid buildup. The goal is to determine which drug more effectively reduces fluid overload, which can cause serious issues like breathing problems or infections. Individuals with liver cirrhosis who have recently been prescribed either bumetanide or furosemide in the hospital may be suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bumetanide is usually well-tolerated for treating liver conditions. In one study, 15 out of 17 patients with chronic liver disease responded well to bumetanide, suggesting its effectiveness for many with these conditions. However, it can sometimes cause rapid changes in blood salts and minerals, potentially leading to liver-related problems like brain dysfunction.

Furosemide is also commonly used for liver cirrhosis and has been studied for its efficacy and safety. Although specific safety details are not mentioned, its widespread use suggests it is generally considered safe, though it can have side effects like any medication.

Both bumetanide and furosemide are diuretics that help the body remove excess fluid. They have been used in patients with liver issues, and studies indicate they are usually safe, but individual responses can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because both bumetanide and furosemide are diuretics, but they differ in their potency and duration of action. Bumetanide is known for its high potency and rapid onset, which may provide faster relief of fluid retention in liver cirrhosis compared to standard diuretics like spironolactone. Furosemide, while also effective, is typically less potent than bumetanide but can be advantageous for those needing a gentler diuretic action. These differences in action and potency are key reasons why researchers are exploring their potential benefits for patients with liver cirrhosis.

What evidence suggests that this trial's treatments could be effective for liver cirrhosis?

This trial will compare Bumetanide and Furosemide for treating fluid buildup in people with liver cirrhosis. Research has shown that both Bumetanide and Furosemide can help manage this condition. One study found that Bumetanide reduced abdominal fluid in 15 out of 17 patients with chronic liver disease. It acts quickly and remains in the body longer, potentially making it more effective than Furosemide for some individuals. Furosemide also effectively manages cirrhosis by reducing fluid retention. Both treatments have demonstrated efficacy, but Bumetanide might be preferable for some due to its mechanism of action. Participants in this trial will receive either Bumetanide or Furosemide to evaluate their effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Stacy A Johnson, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Furosemide Experimental Treatment 1 Intervention

Group II: Bumetanide Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stacy Johnson

Lead Sponsor

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1413073/

Use of bumetanide in the treatment of ascites due to liver ... Bumetanide is an effective diuretic for the treatment of ascites. Fifteen out of 17 patients with chronic liver disease responded satisfactorily.

2. gut.bmj.com gut.bmj.com/content/15/12/988

Use of bumetanide in the treatment of ascites due to liver ... Abstract. Bumetanide is an effective diuretic for the treatment of ascites. Fifteen out of 17 patients with chronic liver disease responded satisfactorily and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06941415

NCT06941415 | Bumetanide vs. Furosemide in Cirrhosis Bumetanide has a theoretic advantage over furosemide due to its more rapid and complete intestinal absorption, combined with a prolonged half-life in patients ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/338256/

Treatment of fluid retention in cirrhosis Both drugs proved effective in controlling ascites and oedema, 9 out of the 10 patients showing a satisfactory response. Minor side-effects, hypokalaemia and ...

5. withpower.com withpower.com/trial/phase-3-liver-cirrhosis-6-2025-99c49

Bumetanide vs. Furosemide for Liver Cirrhosis (BUFF Trial) Bumetanide has a longer duration of action (12 hours) compared to furosemide (6 hours), although this difference is not clinically significant.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11152790/

Diuretic use in patients with cirrhosis and complications of ... In small-scale trials of patients with cirrhosis, torsemide is safe and induces greater diuresis and natriuresis than furosemide with potassium- ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf

bumex - accessdata.fda.gov In patients with hepatic cirrhosis and ascites, sudden alterations of electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such ...