Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- 5 day treatment failure
研究概览
简要总结
Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.
详细描述
Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of liver cirrhosis;
- •Child-Pugh B or C;
- •Acute gastroesophageal variceal bleeding;
- •Written informed consents. -
排除标准
- •No liver cirrhosis;
- •Child-Pugh class A;
- •Acute upper gastrointestinal bleeding unrelated to varices;
- •Use of somatostatin or octreotide. -
研究组 & 干预措施
Continuous infusion of terlipressin
In our clinical practice, continuous infusion of terlipressin is being employed.
干预措施: Terlipressin (Drug)
Bolus infusion of terlipressin
Traditionally, a bolus infusion of terlipressin is recommended.
干预措施: Terlipressin (Drug)
结局指标
主要结局
5 day treatment failure
时间窗: 5 days (120 hours)
Death, fresh hematemesis, hypovolaemic shock, or 3 g drop in Hb (9% drop of Ht) within any 24 h period if no transfusion is administered.
次要结局
- Six-week mortality(6 weeks)
研究者
Xingshun Qi
Doctor
General Hospital of Shenyang Military Region