Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.

Institute of Liver and Biliary Sciences, India126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Alcoholic Hepatitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

increase in Survival at 90 days in all the groups.

Time frame: 90 days

Secondary Outcomes

Improvement in CTP (Child-Pugh Score) in all the groups.

CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.

Time frame: Day 28