Steroids in Fulminant Hepatitis A in the Pediatric Age Group

Study Overview
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Brief Summary
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Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The mortality rate may reach 80-90% in the absence of liver transplantation. Liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. For that, it is suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.

Detailed Description
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Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The mortality rate may reach 80-90% in the absence of liver transplantation. FHF is the clinical manifestation of liver cell death of a critical degree with insufficient hepatocellular regeneration and characterized by coagulopathy with or without hepatic encephalopathy. Liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. For that, it was suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.

Official Title
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Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group

Conditions
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Fulminant Hepatic Failure

Intervention / Treatment
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* Drug: prednisolone
* Drug: methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is diagnosed to have FHF, if he fulfilled all the following criteria: Evidence of liver dysfunction within 8 weeks of onset of symptoms (neonates may have only deranged liver functions without overt symptoms). Uncorrectable coagulopathy (6-8 hours after administration of one dose of parenteral vitamin K) with International Normalized Ratio (INR) >1.5 in patients with hepatic encephalopathy, or INR> 2.0 in patients without encephalopathy. No evidence of chronic liver disease. Exclusion Criteria: 1. Presence of absolute contra-indications to steroid therapy (as presence of an active gastrointestinal bleeding, renal failure, acute pancreatitis, active tuberculosis, uncontrolled diabetes and psychosis).

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prednisolone<br>This group includes patients with FHF without encephalopathy | Drug: prednisolone<br>* Oral administration of 1 mg/Kg/day<br>* Other names: Hostacortin-H;|
| Active Comparator: methylprednisolone<br>This group includes patients with FHF with encephalopathy | Drug: methylprednisolone<br>* Intravenous injection of 0.8 mg/kg/day<br>* Other names: Solumedrol;|
| No Intervention: Non-intervention<br>FHF patients without any of the proposed intervention as controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect 1 Number of patients with anaphylaxis | Number of patients with anaphylaxis | 2 months | 
| Side effect 2 Number of patients with angioedema | Number of patients with angioedema | 2 months | 
| Side effect 3 Number of patients with cardiac arrest | Number of patients with cardiac arrest | 2 months | 
| Side effect 4 Number of patients with arrhythmias | Number of patients with arrhythmias | 2 months | 
| Side effect 5 Number of patients with circulatory collapse | Number of patients with circulatory collapse | 2 months | 
| Side effect 6 Number of patients with congestive heart failure | Number of patients with congestive heart failure | 2 months | 
| Side effect 7 Number of patients with pulmonary edema | Number of patients with pulmonary edema | 2 months | 
| Side effect 8 Number of patients with pancreatitis | Number of patients with pancreatitis | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy 1 Number of survivors | number of living patients | 2 months | 
| Efficacy 2 Number of deaths | number of died patients | 2 months | 
| Efficacy 3 serum prothrombin time | serum prothrombin time | 72 hour | 
| Efficacy 3 grade of encephalopathy | grade of encephalopathy | 72 hour | 
| Efficacy 4 duration of encephalopathy | duration of encephalopathy | 2 months |