University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Location status: Recruiting
Location contact
Andrea T White, PhD
CONTACT
Stacy A Johnson, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06941415
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Salt Lake City, Utah, 84132, United States
Location status: Recruiting
Andrea T White, PhD
CONTACT
Stacy A Johnson, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard of care treatment with bumetanide (intravenous or oral administration) per treating clinician's orders
Standard of care treatment with furosemide (intravenous or oral administration) per treating clinician's orders
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
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
Time frame: 14 days
New initiation of intermittent or continuous hemodialysis within 14 days of presentation to the emergency department
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
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
Time frame: 30 days
Readmission to the hospital for an unexpected reason within 30 days of a prior hospital admission
Time frame: 30 days
Death occurring within the 30 days following presentation to the emergency department and subsequent hospital admission
Contact information is provided by the study sponsor or research team.
Stacy Johnson
Other
Bumetanide vs. Furosemide for Adults Hospitalized With Cirrhosis: the BUFF Trial
Acronym: BUFF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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