refractory ascites with liver cirrhosis
Conditions
Interventions
experimental group:Standard medical treatment plus intake empagliflozin 10mg Qd
control group:Receiving standard treatment, with the restriction of not using SGLT2 inhibitors
Sponsors
Beijing Youan Hosptial, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old, gender is not limited; 2. Diagnostic criteria for cirrhosis: Evidence of hepatocellular synthetic dysfunction or portal hypertension from imaging, biochemical, or hematological tests, or histological findings consistent with a diagnosis of cirrhosis. 3. Diagnostic criteria for refractory ascites: i) No response to treatment after more than 1 week of diuretic therapy (spironolactone 80–160 mg/d, furosemide 40–80 mg/d) or 2 weeks of therapeutic intermittent paracentesis combined with human albumin treatment; ii) Inability to tolerate increased doses of diuretics in the past; iii) Development of difficult-to-control complications or adverse reactions related to diuretics; iv) Exclusion of ascites caused by malignant ascites or prehepatic portal hypertension. The diagnosis of refractory ascites should meet the criteria of i), ii), or iii), plus iv). 4. The patient has the ability to make independent decisions and sign the informed consent form independently.
Exclusion criteria
Exclusion criteria: 1. Systolic blood pressure less than 95 mmHg or diastolic blood pressure less than 60 mmHg within 1 week. 2. Laboratory tests within 1 week indicating eGFR < 45 mL·min-1·1.73m-2. 3. History of esophageal or gastric variceal rupture and bleeding within the past 3 months. 4. History of hepatic encephalopathy greater than grade II within the past 3 months. 5. Liver cancer patients. 6. History of alcohol abuse or drug addiction within the past 6 months. 7. History of alcohol consumption within 2 weeks prior to enrollment. 8. Use of SGLT2 inhibitors within the past 3 months. 9. MELD score greater than 20 or expected median survival less than 6 months. 10. Presence of spontaneous or secondary bacterial peritonitis. 11. Last laboratory test prior to enrollment indicating anemia with hemoglobin less than 7 g/dL. 12. Use of diuretics other than spironolactone or furosemide within the past 1 weeks, such as tolvaptan or thiazide diuretics. 13. Severe heart failure with significant left ventricular ejection dysfunction, with BNP greater than 1000 ng/mL or left ventricular ejection fraction less than 40% within the past 3 months. 14. History of bladder dysfunction, severe prostate hypertrophy, or urinary incontinence. 15. History of urinary tract infection within 3 months prior to enrollment, or indication of urinary tract infection at screening, such as pyelonephritis or cystitis. 16. Within 3 months, there has been fungal vaginitis, phimosis, or balanitis. 17. Blood sodium levels are below 125mmol/L within one week. 18.Symptomatic hypoglycemia within the past 3 months. 19.Participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fractional excretion of sodium; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour total urinary sodium excretion ;24-hour total urine volume;body weight change;average daily drainage volume of ascites;changes in ascites volume; | — |
Countries
China
Contacts
Public ContactZhongjie Hu
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed