Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Albumin with SMT: Patients with serum albumin 3 g/L with recurrent ascites - Will receive 20 % albumin at 60 grams/week until target serum albumin of 3.0 g/L is achieved following this
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with cirrhosis of liver with recurrent ascites. 2) Patients with age from 18-70 years
Exclusion criteria
Exclusion criteria: 1. Renal failure (Creatinine >1.5mg/dl) 2. Recent Gastrointestinal bleeding within 7 days 3. Spontaneous bacterial Peritonitis 4. Patients with organic nephropathy ( as defined by IAC) 5. Patients with Cardiovascular disease or chronic obstructive pulmonary disease 6. Systemic arterial hypertension ( >160/90mmhg) 7. Presence of hepatocellular carcinoma (outside Milan criteria)( or portal vein thrombosis 8. Budd-Chiari Syndrome 9. Patients with active sepsis 10. Pregnancy 11. Patients with hepatic encephalopathy 12. No use of drugs affecting systemic hemodynamics 7 days prior to enrolment (except beta-blockers) 13. Patients with serum albumin >3 gm 14. Refusal to participate 15. Known or suspected hypersensitivity to albumin 16. Prior TIPS 17. Post liver or kidney transplantation 18. Patients enrolled in other clinical trials 19. Extrahepatic malignancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in immune parametersTimepoint: 3 and 6 months;Improvement in quality of Life as assessed by short form survey-36 version (SF-36)Timepoint: 6 and 12 months;Improvement in renal reserve (as assessed by renal biomarkers)Timepoint: 3,6 and 12 months;Incidence of liver-related complicationsTimepoint: 3,6 and 12 months;MortalityTimepoint: 12 months;Reduction in the frequency of large volume paracentesisTimepoint: 3,6 and 12 months;Survival free of liver transplant and TIPS in both groupsTimepoint: 6 months and 1 year | — |
Primary
| Measure | Time frame |
|---|---|
| MortalityTimepoint: 6 Months | — |
Countries
India
Contacts
Public ContactDr Rakhi Maiwall
Institute of Liver and Biliary Sciences
Outcome results
None listed