Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: K00-K95- Diseases of the digestive system
Conditions
Interventions
Intervention1: Empagliflozin: Empagliflozin 10 mg/day for 8 weeks in addition to Standard of Care Therapy (Dietary sodium restriction, Diuretics, IV albumin and Large Volume Paracentesis as required)
Sponsors
Dayanand Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Cirrhosis (clinical, imaging, and/or histological) with refractory ascites (due to portal hypertension). Subjects who are willing and able to comply with treatment plan, laboratory tests. Subjects who are willing to provide a written informed consent
Exclusion criteria
Exclusion criteria: - Previous history of documented hypoglycemia (in the preceding 1 month) - Previous history of repeated urinary tract infection (UTI) (more than 2 infections within 6 months), - Pregnant or lactating females, - Previous history of hypersensitivity to any SGLT2 inhibitor - Serum sodium - History of peripheral vascular disease (ulcer/gangrene/amputation) - Severe renal impairment (eGFR - Active alcohol use with last alcohol intake 1 month back - GI bleeding in the previous 1 month - Overt HE in the previous 1 month - Treatment with drugs with known effects on systemic and renal hemodynamics within 7 days of inclusion, except beta blockers - Previous history of diabetic ketoacidosis, - Child Pugh score of 12 or more - Hepatocellular carcinoma - Portal Vein Thrombosis - SBP - Mixed ascites (etiology of ascites other than portal hypertension) - Patients opting for liver transplant or TIPS - H/o pancreatitis/pancreatic surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of therapeutic paracenteses per patient and total paracentesis volume during 12 weeksTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in abdominal girth (cm) from baselineTimepoint: Weeks 4, 8 and 12;Change in body weight (kg)Timepoint: Weeks 4, 8 and 12;Change in eGFR from baselineTimepoint: Weeks 4, 8 and 12;Change in HbA1cTimepoint: 12 weeks;Change in prognostic scores (CTP, MELD Na) from baselineTimepoint: Weeks 4, 8 and 12;Change in serum sodium and spot urinary sodiumTimepoint: Weeks 4, 8 and 12;Incidence of AKI (as per KDIGO), serious adverse events (including SGLT2-i related AEs)Timepoint: 12 weeks;Frequency of hepatic encephalopathyTimepoint: 12 weeks;Frequency of SBP, UTI and other infectionsTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Varun Mehta
DMCH Ludhiana
Outcome results
None listed