Cirrhosis
Conditions
Keywords
cirrhosis, volume overload, diuresis, furosemide, bumetanide
Brief 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 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
DRUGBumetanide
Standard of care treatment with bumetanide (intravenous or oral administration) per treating clinician's orders
DRUGFurosemide
Standard of care treatment with furosemide (intravenous or oral administration) per treating clinician's orders
Sponsors
Stacy Johnson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in weight | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for replacement therapy | 14 days | New initiation of intermittent or continuous hemodialysis within 14 days of presentation to the emergency department |
| Severe electrolyte derangement | 14 days | New decrease in serum potassium to less than 2.5 mEq/L within 14 days of presentation to the emergency department |
| Development of acute kidney injury | 14 days | Stage 2 or higher acute kidney injury developing within 14 days of presentation to emergency department in accordance with KDIGO criteria |
| Unplanned hospital readmission | 30 days | Readmission to the hospital for an unexpected reason within 30 days of a prior hospital admission |
| 30-day mortality | 30 days | Death occurring within the 30 days following presentation to the emergency department and subsequent hospital admission |
| Hospital length of stay | 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 |
Countries
United States
Contacts
Primary ContactAndrea T White, PhD
Outcome results
None listed