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Recruiting NCT06941415

Bumetanide vs. Furosemide in Cirrhosis

Phase III Interventional Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bumetanide, Furosemide.
Who it may be relevant to
Registry conditions: Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Bumetanide vs. Furosemide for Adults Hospitalized With Cirrhosis: the BUFF Trial

Overview

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.

Interventions

  • Drug Bumetanide
    Standard of care treatment with bumetanide (intravenous or oral administration) per treating clinician's orders
  • Drug Furosemide
    Standard of care treatment with furosemide (intravenous or oral administration) per treating clinician's orders

Primary outcome measures

  • Percent change in weight [Time frame: 7 days]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Utah Hospital — Salt Lake City

Identifiers

NCT: NCT06941415 · IRB_00186841

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗