NCT02583698已完成不适用
Efficacy of Nonselective Beta Blockers vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Mortality in both groups
研究概览
简要总结
Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute on Chronic Liver Failure as per APASL (Asian Pacific Association of Study of Liver Disease) criteria.
- •18-75 years
- •HVPG ≥ 12 + No/Small Esophageal varices
排除标准
- •Bradycardia (HR < 60/ min)
- •Hypotension
- •AKI (Acute Kidney Injury), (S.creat >1.5)
- •Refractory ascites
- •SBP (Spontaneous Bacterial Peritonitis)
- •Pregnancy or Lactation
- •Past history of EVL or EST
- •Significant cardio - pulmonary co-morbidity
- •Presence of grades 3-4 hepatic encephalopathy (HE)
- •Patients going for liver transplant in next 12 weeks
研究组 & 干预措施
Carvedilol
Experimental
Tab Carvedilol 3.125 mg twice daily followed by 6.25 mg BD and finally 12.5 mg BD if SBP > 90 mmHg and HR >55/min
干预措施: Carvedilol (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mortality in both groups
时间窗: 28 days
次要结局
- Number of patients with development or progression of esophageal varices in both groups.(3 Months)
- Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups.(3 Months)
- Number of patients with development of adverse events in both groups in both groups.(3 Months)
- Number of patients with regression in esophageal varices in both groups.(3 Months)
- Number of patients with improvement in Liver severity scores in both groups.(3 months)
- Number of patients who will develop esophageal variceal bleeding in both groups(3 Months)
- Development of complications in both groups(3 months)
- Mortality in both groups(3 months)
研究者
研究点 (1)
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