Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Side effect 4 Number of patients with arrhythmias
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
methylprednisolone
This group includes patients with FHF with encephalopathy
干预措施: methylprednisolone (Drug)
prednisolone
This group includes patients with FHF without encephalopathy
干预措施: prednisolone (Drug)
结局指标
主要结局
Side effect 4 Number of patients with arrhythmias
时间窗: 2 months
Number of patients with arrhythmias
Side effect 8 Number of patients with pancreatitis
时间窗: 2 months
Number of patients with pancreatitis
Side effect 3 Number of patients with cardiac arrest
时间窗: 2 months
Number of patients with cardiac arrest
Side effect 2 Number of patients with angioedema
时间窗: 2 months
Number of patients with angioedema
Side effect 1 Number of patients with anaphylaxis
时间窗: 2 months
Number of patients with anaphylaxis
Side effect 5 Number of patients with circulatory collapse
时间窗: 2 months
Number of patients with circulatory collapse
Side effect 6 Number of patients with congestive heart failure
时间窗: 2 months
Number of patients with congestive heart failure
Side effect 7 Number of patients with pulmonary edema
时间窗: 2 months
Number of patients with pulmonary edema
次要结局
- Efficacy 1 Number of survivors(2 months)
- Efficacy 2 Number of deaths(2 months)
- Efficacy 3 serum prothrombin time(72 hour)
- Efficacy 3 grade of encephalopathy(72 hour)
- Efficacy 4 duration of encephalopathy(2 months)
研究者
Mostafa M. Sira
Associate Professor of Pediatric Hepatology
National Liver Institute, Egypt