Evaluation of pulse dose corticosteroids in patients with severe alcoholic hepatitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To identify and compare the survival of patients on standard of care treatment and pulse dose steroids.
研究概览
简要总结
Regular dose steroids have been proven to be useful in the treatment of patients with severe alcoholic hepatitis but are associated with adverse effects including infections . Pulse dose steroids have been proven useful in various rheumatological, dermatological diseases and acute transplant rejections with equally good efficacy as regular daily dose steroids and lesser side effects. In this trial we intend to study the efficacy and side effects of pulse dose methylprednisolone in patients with severe alcoholic hepatitis.Patients diagnosed with severe alcoholic hepatitis are assessed for eligibility and given 3 doses of pulse dose methylprednisolone and followed up for 6 weeks. At the end of 6weeks the mortality rated and side effect profile are assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All the patients greater than 18years of age with diagnosed Severe Alcoholic hepatitis with mDF (Maddrey’s Discriminant function) greater than 32 with or without underlying cirrhosis are included.
排除标准
- •Patients with evidence of active GI bleed,active Infections/ Sepsis,patients with mDF greater than 90,patients with encephalopathy,patients with AKI/ Renal failure,patients requiring inotropic support,not willing to give consent.presence of other liver diseases and pregnant women.
结局指标
主要结局
To identify and compare the survival of patients on standard of care treatment and pulse dose steroids.
时间窗: The patients and the outcomes will be assessed at 4th day, at 2 weeks, at 4 weeks and at 6 weeks.
次要结局
- To identify the appropriate dose and side effects profile of patients on pulse dose steroids.(6weeks)
研究者
Dr Prachis Ashdhir
SMS Medical College and Attached hospitals