Alcoholic Hepatitis
Conditions
Brief summary
The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.
Interventions
DRUGGcsf
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
DRUGPrednisolone
Prednisolone 40 mg for initial 7 days
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.
Exclusion criteria
* Presence of active infections * Acute Gastrointestinal bleed * Hepatorenal syndrome * Patient unwilling * Discriminant Function \>90 * Autoimmune hepatitis * Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases * Pregnancy * Hemophagocytic lymphohistiocytosis (HLH) * Hb\<8 and baseline White Blood Cell\>25000
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| increase in Survival at 90 days in all the groups. | 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in CTP (Child-Pugh Score) in all the groups. | Day 28 | CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst. |
| Improvement in MELD (Model for End Stage Liver Disease) in all the groups. | Day 28 | A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests. |
Countries
India
Contacts
Primary ContactDr Ajay Mishra, MD
Outcome results
None listed