Comparison of no vasoactive agent with 1-day vasoactive agent after endoscopic variceal ligation in patients with cirrhosis presenting with acute variceal bleeding: an open-label non-inferiority trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- 1. Cumulative 6-week rebleeding rates after recruitment, assessed using per-protocol and intention-to-treat analysis
研究概览
简要总结
In this study we aim to assess the effect of vasoactive drugs on control of variceal bleeding in patients with liver cirrhosis. Patients will be given all medications as per standard indications for control of bleeding and treatment of liver disease. Patients will have an equal chance of receiving vasoactive agents(somatostatin) for either 1 day or no therapy after endoscopic hemostasis has been achieved. They will be followed up for 6 weeks to look for re bleeding rates, mortality, all cause decompensation.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Cirrhosis (Child A,Child B and Child C) with acute esophageal variceal bleeding for whom adequate endotherapy has been performed
- •Age between 18-65 years
- •Willing to participate in the study.
排除标准
- •Patients already included in the trial presenting with repeat variceal bleeding
- •Failure to achieve primary hemostasis
- •Bleeding from cardiofundal varices
- •Portosinusoidal vascular disorders, and splanchnic vein thrombosis
- •History of prior TIPS or TIPS thrombosis
- •Acute-on-chronic liver failure as per the European Association for the Study of Liver definition
- •Overt Hepatic encephalopathy
- •Patients with any co-existent malignancy including HCC
- •Patients with bleeding diathesis.
- •Pregnant women
- •Patients with renal dysfunction serum creatinine greater than 2 mg per dL
- •Patients with sepsis, shock or requiring mechanical ventilation
- •Contraindications to NSBBs including prior documented hypersensitivity, unacceptable adverse events including hypotension or dizziness and cardiac comorbidities such as heart block.
结局指标
主要结局
1. Cumulative 6-week rebleeding rates after recruitment, assessed using per-protocol and intention-to-treat analysis
时间窗: 1. Cumulative 6-week rebleeding rates after recruitment, assessed using per-protocol and intention-to-treat analysis
次要结局
- 1. 5-day rebleeding rates with mortality and transplant as competing events(2. 6-week all-cause decompensation, with mortality as additional competing event)
研究者
Dr Shalimar
AIIMS, New Delhi