Acute on Chronic Liver Failure
Conditions
Brief summary
Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. These patients will be assessed for the liver transplant free survival at 28 days and complications \[PHT related bleed, AKI, infections, HE\] within 90 days; transplant-free survival rate at 90 days; evolution of the AARC score for 2 wk.
Interventions
Carvedilol 12.5 mg
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of ACLF (APASL criteria) - jaundice (serum bilirubin ≥ 5 mg/dL and coagulopathy (INR ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, 2. Age 18-70 yrs 3. Baseline HVPG ≥ 12 mmHg.
Exclusion criteria
1. Contraindications to NSBB (heart rate \< 65 /min, BP \< 110/65 mm Hg, asthma, heart failure), 2. Portal Vein Thrombosis, 3. Hepatocellular carcinoma, 4. HVOTO, 5. HE grades 2-4, 6. NSBB therapy within 5 days, 7. Pregnancy, 8. Lactation, 9. Planned for LT in the next 12 weeks 10. No consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver transplant free survival | Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Complications [PHT related bleed, AKI, infections, HE] within 90 days | 90 days |
| Liver transplant-free survival rate | 90 days |
| Correlation with evolution of AARC score | 2 weeks |
Countries
India
Contacts
Primary ContactDr Chitranshu Vashishtha, DM
Outcome results
None listed