Empagliflozin in Patients With Cirrhosis and Ascites

Exclusion Criteria21

• Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)
• Direct bilirubin \>=3 mg/dL
• Systolic blood pressure \< 100 mmHg
• Active malignancy including hepatocellular carcinoma undergoing treatment
• History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
• Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance
• Type 1 diabetes
• History of frequent hypoglycemic episodes
• Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor.
• Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks
• Hepatic encephalopathy grade II or greater at the time of enrollment
• Patients who have had TIPS placed
• Previous liver transplant
• Participation in another trial with an investigational drug within the 30 days prior to informed consent
• Pregnancy or breastfeeding
• Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)
• Change in diuretic dose in the prior 2 weeks
• Patients with hospitalization for alcoholic hepatitis in the past 6 months
• Significant worsening of creatinine (more than 50% increase) in the past 4 weeks
• MELD-Na \> or equal to 20
• Hemoglobin \<8