Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function- A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Liver transplant free survival at 28 days, 90 days.
研究概览
简要总结
Hypothesis: we hypothesise that the early treatment with therapeutic plasma exchange in alcoholic hepatitis patients might improve overall survival in carefully selected patients by removing cytokines, chemokines and toxic substances.
Aim: To compare transplant free survival between plasma exchange therapy and standard medical therapy in severe alcoholic hepatitis
Methodology:
Severe alcoholic hepatitis will be screened for the study and will be managed with SMT initially will be assessed for steroid therapy if becomes ineligible counselled for liver transplant in view of high DF and MELD ,if there is no options of Liver transplant in near future ,1 month will be given option for PLEX but it will be decided by randomisation whether he will get SMT or PLEX.He/she will also be told that PLEX is not a approved treatment and is a trial therapy and they may or may not get benefited.Patients Patients who agreed to undergo PLEX then undergo randomisation between PLEX and SMT and allocated in either group accordingly.
Control group will be administered SMT only.Case are those who get both SMT and PLEX. SMT involved empirical antibiotics as per treating physician,multivitamins,albumin. Hepatic encephalopathy (HE) will be treated with lactulose and rifaximin. Ascites with diuretics if not contraindicated because of renal insufficiency or HE. All patients will receive salt restricted, high protein diet (1.5 g/kg of proteins) either enterally/parenterally in addition to thiamine and multivitamins,35 to 45 kcal /kg .
Cases will be administered SMT with Plasma exchange session which will be done on alternate day to a maximum of 5 sessions. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session,no improvement in clinical condition and Intolerant to PLEX procedure
Study population:
1. 1) Age - 18-60 years
2. 2) Patients with steroid ineligible (DF > 80< 120, MELD > 30) severe alcoholic hepatitis (Bili > 5 ,INR > 1.5)
Study Design: Randomised controlled study done at Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 60 years
- •Severe alcoholic hepatitis with DFmore than 80 and less than 120 or MELD more than 30
- •No liver transplant option available in near future(for atleast 1 month)
- •Patient able to bear the cost of Plasma exchange by himself/herself.
排除标准
- •Active sepsis
- •S creatinine more than 1.5mg per dl
- •Chronic kidney disease
- •Pregnancy
- •HCC or any other malignancy
- •Active Bleeding
- •Allergic to replacement fluid (FFP) in TPE
- •Severe Hypocalcemia (less than 7.6 mg per dl)
- •Failure to give consent
- •Financial issues to bear cost of Plasma exchange.
结局指标
主要结局
Liver transplant free survival at 28 days, 90 days.
时间窗: 28 days, 90 days.
次要结局
- End of study period (90 Days)(90 days)
- Mortality at 28 days(28 days)
- Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present)(28 days)
- Frequency of decompensation events on follow up period(28 days)
研究者
Dr Jitendra Kumar Singh
Institute of Liver and Biliary Sciences