Fulminant Hepatic Failure
Conditions
Brief summary
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
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.
Interventions
DRUGprednisolone
Oral administration of 1 mg/Kg/day
DRUGmethylprednisolone
Intravenous injection of 0.8 mg/kg/day
Sponsors
Quesna Central Hospital, Ministry Of Health, Egypt
National Liver Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
The patient is diagnosed to have FHF, if he fulfilled all the following criteria: 1. Evidence of liver dysfunction within 8 weeks of onset of symptoms (neonates may have only deranged liver functions without overt symptoms). 2. 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. 3. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side effect 8 Number of patients with pancreatitis | 2 months | Number of patients with pancreatitis |
| Side effect 3 Number of patients with cardiac arrest | 2 months | Number of patients with cardiac arrest |
| Side effect 4 Number of patients with arrhythmias | 2 months | Number of patients with arrhythmias |
| Side effect 5 Number of patients with circulatory collapse | 2 months | Number of patients with circulatory collapse |
| Side effect 6 Number of patients with congestive heart failure | 2 months | Number of patients with congestive heart failure |
| Side effect 7 Number of patients with pulmonary edema | 2 months | Number of patients with pulmonary edema |
| Side effect 1 Number of patients with anaphylaxis | 2 months | Number of patients with anaphylaxis |
| Side effect 2 Number of patients with angioedema | 2 months | Number of patients with angioedema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy 1 Number of survivors | 2 months | number of living patients |
| Efficacy 2 Number of deaths | 2 months | number of died patients |
| Efficacy 3 serum prothrombin time | 72 hour | serum prothrombin time |
| Efficacy 3 grade of encephalopathy | 72 hour | grade of encephalopathy |
| Efficacy 4 duration of encephalopathy | 2 months | duration of encephalopathy |
Countries
Egypt
Outcome results
None listed