NCT03005587撤回不适用
Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation - A Prospective Observational Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Spontaneous recovery or liver transplant or death in both groups
研究概览
简要总结
This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . A detailed proforma including history and examination and routine blood investigations will be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation.
- •Age 18-70 years
- •Valid consent
排除标准
- •HepatoCellular Carcinoma
- •Admitted and survival less than 48 hrs
- •Acute Liver Failure
- •Post transplant
结局指标
主要结局
Spontaneous recovery or liver transplant or death in both groups
时间窗: 90 days
次要结局
- Causes of death in both groups(3 months)
- Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups(3 months)
- Improvement in severity assessment Indices CLIF score in both groups(3 months)
- Cause of acute decompensation(3 months)
- Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups.(3 months)
- Improvement in severity assessment Indices Child Pugh Turcotte in both groups.(3 months)
- Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups(3 months)
- Sepsis in both groups(3 months)
- Systemic Inflammatory Response Syndrome in both groups(3 months)
- Severity and duration of prior as well as present decompensation(3 months)
- Profile of patient undergone transplant in both groups(3 months)
研究者
研究点 (1)
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