Empagliflozin in Diuretic Refractory Ascites

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Ascites is the most frequent complication of liver cirrhosis and results in increased morbidity and mortality but current medical management options are limited. Here, the investigators will conduct an interventional single-arm pilot clinical trial toevaluate the feasibility of empagliflozin in managing diuretic-resistant ascites in patients with decompensated cirrhosis. This single site, open label pilot study will enroll participants with decompensated cirrhosis at a single site. Participants will receive empagliflozin 10mg oral tablets once daily for 12 weeks with monitoring for safety and adverse events.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Decompensated liver cirrhosis with ascites

• Diuretic-resistant ascites defined as one of the following: a) An inability to mobilize ascites despite adherence to dietary sodium restriction (2000 mg per day) and administration of maximum tolerable doses of oral diuretics; b) Rapid reaccumulation of fluid after therapeutic paracentesis despite adherence to a sodium-restricted diet. c) Development of diuretic-related complications such as progressive azotemia, hepatic encephalopathy, or progressive electrolyte imbalances

• Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

• Hypersensitivity to any SGLT2 inhibitor

• Pregnant or breastfeeding women

• eGFR below 45mL/min/1.73m2 or decrease in eGFR by >30% between screening

• Recurrent urinary tract infections or recurrent genitourinary fungal infections, defined as > 2 infections in six months or >3 infections in one year

• Hypotension requiring oral vasopressor therapy

• Patients with particular risk for ketoacidosis including active moderate or severe alcohol use disorder, pancreatitis, pancreatic insulin deficiency from any cause, or episode of ketoacidosis in the past

• History of skin or soft tissue infection requiring IV antibiotics including Fornier's gangrene or prior limb amputation

• Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial