An Exploratory Study on the Efficacy and Safety of Short-Term Empagliflozin Administration for Cirrhotic Ascites Resistant to Standard Diuretic Therapy

未提供0 个研究点目标入组 10 人开始时间: 待定

适应症

试验速览

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•(1) Patients diagnosed with liver cirrhosis
•(2) Patients diagnosed with Type 2 diabetes mellitus
•(3) Patients with poor ascites control despite appropriate administration of standard diuretic therapy (spironolactone and furosemide) for 7 days or more
•(4) Patients who refuse inpatient induction of tolvaptan based on patient preference
•(5) Patients with eGFR >= 45 mL/min/1.73 m^2
•(6) Patients with serum sodium levels >= 130 mmol/L
•(7) Patients with Child-Pugh classification B and MELD-Na score >= 15
•(8) Patients with mean blood pressure >= 75 mmHg, or systolic blood pressure >= 100 mmHg
•(9) Patients aged >= 18 years and < 85 years at the time of obtaining consent
•(10) Gender is not limited (Any gender)
•(11) Patients who have provided written informed consent of their own free will after receiving a full explanation regarding participation in this study and fully understanding it
•(12) Patients capable of outpatient visits according to the study schedule

•(1) Patients with portal vein thrombosis
•(2) Patients with untreatable hepatocellular carcinoma
•(3) Patients who presented with gastrointestinal bleeding within 2 weeks
•(4) Patients who presented with overt hepatic encephalopathy within 4 weeks
•(5) Patients who initiated, changed the dose of, or discontinued glucose-lowering agents (including insulin) within 4 weeks prior to obtaining consent
•(6) Patients who presented with hypoglycemic attacks within 4 weeks
•(7) Patients with active infection within 4 weeks
•(8) Patients with anatomical abnormalities causing urinary tract infections
•(9) Patients currently taking SGLT2 inhibitors
•(10) Patients currently taking tolvaptan
•(11) Patients with a history of Type 1 diabetes or diabetic ketoacidosis (DKA)
•(12) Patients judged to be at high risk for developing ketoacidosis due to excessive alcohol consumption, poor dietary intake, or strict low-carbohydrate diet
•(13) Patients with surgery or severe trauma within 4 weeks prior to obtaining consent, or those scheduled for surgery during the study period
•(14) Patients with a history of hypersensitivity to empagliflozin
•(15) Patients who are pregnant or possibly pregnant
•(16) Patients who are breastfeeding
•(17) Other patients judged inappropriate for participation in this study by the Principal Investigator or Co-Investigator

发起方

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