Refractory Cirrhotic Ascites
Conditions
Interventions
Interventin group:Empagliflozin 10mg oral Qd plus standard care
Control group :Standard care
Sponsors
Baoding People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years. 2. Body weight (including ascites) >=50 kg, and body mass index (BMI) between 18 and 35 kg/m². 3. Patients with relatively stable decompensated liver cirrhosis and ascites (as determined by a senior hepatologist), defined as: – Doses of spironolactone and furosemide have remained relatively stable over the past 3 months; – During this period, any increase in either diuretic did not exceed 100%, and any reduction did not exceed 50%; – Ascites has not completely resolved, and diuretic doses have remained unchanged within 2 weeks prior to enrollment. 4. Diagnosed with type 2 diabetes mellitus, with no adjustment in antidiabetic medications within the past 3 months. 5. Estimated glomerular filtration rate (eGFR) >=45 mL·min?¹·1.73 m?². 6. Capable of making independent decisions and able to voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Systolic blood pressure 20 or expected median survival less than 6 months. 9. Anemia, defined as hemoglobin 1000 ng/mL or LVEF <40% within the past 3 months. 12. Presence of bladder dysfunction, severe prostatic hyperplasia, or urinary incontinence. 13. History of urinary tract infection within the past 3 months, or evidence of urinary tract infection at screening, such as pyelonephritis or cystitis. 14. Participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fractional excretion of sodium; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour urinary sodium;24-hour urine volume;otal ascites drainage volume during hospitalization;Body weight change; | — |
Countries
China
Contacts
Public ContactRongya Shi
Baoding People's Hospital
Outcome results
None listed