Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Takeda Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with acute decompensation of cirrhosis 2. Patients with age from 18-65 years
Exclusion criteria
Exclusion criteria: 1. Recent Gastrointestinal bleeding within 7 days 2. Patients with organic nephropathy (as defined by IAC) 3. Patients with Cardiovascular disease or chronic obstructive pulmonary disease 4. Systemic arterial hypertension ( >160/90mmhg) 5. Presence of hepatocellular carcinoma (outside Milan criteria) ( or portal vein thrombosis 6. Budd-Chiari Syndrome 7. Pregnancy 8. Patients with serum albumin >3 gm 9. Refusal to participate 10. Known or suspected hypersensitivity to albumin 11. Prior TIPS 12. Post liver or kidney transplantation 13. Patients enrolled in other clinical trials 14. Extrahepatic malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall mortalityTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Delta change coagulation indices measured by the rotational thromboelastometry before & after albuminTimepoint: 1 & 3 months;Delta change in CRP & IL-6Timepoint: 1 & 3 months;Delta change in the mean arterial pressure in mm of Hg before & after albumin.Timepoint: 1 & 3 months;Incidence of liver-related complications.Timepoint: 1 & 3 months;Proportion of patients achieving recompensation.Timepoint: 1 & 3 months;Proportion of patients with reduction in the AARC grade by 1Timepoint: 1 & 3 months;Proportion of patients with reduction in the MELD score by at least 5 pointsTimepoint: 1 & 3 months;Reduction in the SOFA score by 2 pointsTimepoint: 1 & 3 month;Survival free of liver transplant & TIPS in both groupsTimepoint: 1 & 3 months;The cumulative incidence of infectionsTimepoint: 1 & 3 months | — |
Countries
India
Contacts
Public ContactDr Rakhi Maiwall
Institute of Liver and Biliary Sciences
Outcome results
None listed