Health Condition 1: K74- Fibrosis and cirrhosis of liver
Conditions
Interventions
None listed
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients age 18 to 80 years 2. Patients with probable or definite alcoholic hepatitis (AH) (as per AASLD guidelines) will be enrolled from consecutive patients presenting first time to the department. The diagnosis of AH will be made as per the NIAAA consensus, i.e., • onset of jaundice within the prior eight weeks, • ongoing consumption of >40g (female) or >60 (male)g of alcohol/day for 6 months or more, with less than 60 days of abstinence before the onset of jaundice • aspartate aminotransferase >50, aspartate aminotransferase/alanine aminotransferase >1.5, and both values • serum bilirubin (total) >3.0 mg/dL • liver biopsy confirmation in patients with confounding factors
Exclusion criteria
Exclusion criteria: Patients having: i. HIV infection ii. Prior organ transplantation iii. Hepatic or extra-hepatic malignancy iv. Receiving any experimental therapies v. Pregnant or lactating women, will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impact of GH along with standard medical therapy (SMT) as compared to SMT-alone on overall survival (Time frame 30 days)Timepoint: 30 days and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Proteomic analysis of neutrophils towards unravelling parameters influencing the pathophysiology and outcomes in alcoholic hepatitis (AH) patients. [Time frame: day-0 and day-7]Timepoint: 0-16 months;Transcriptomic analysis of neutrophils to define molecular signatures linked to pathophysiology and outcomes in alcoholic hepatitis (AH) patients. [Time frame: day-0 and day-7]Timepoint: 0-16 months;Validation of identified transcriptomic and proteomic signatures associated with prognosis in alcoholic hepatitis (AH) patients. [Time frame: day-0 and day-7]Timepoint: 18-34 months | — |
Countries
India
Contacts
Public ContactDr Nipun Verma
PGIMER, CHandigarh
Outcome results
None listed