Hemodynamic Effects of Terlipressin and High Dose Octreotide on Patients With Liver Cirrhosis Related Esophageal Varices: A Randomized, Placebo-controlled Multicenter Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Fluctuation of HVPG
研究概览
简要总结
The purpose of the study is to find patients's response to terlipressin and octreotide during hepatic venous pressure gradient measurement by observing portal and systemic hemodynamics.
详细描述
Esophageal variceal bleeding is one of the main causes of death in cirrhosis patients. Prevention of bleeding events, including primary and secondary prophylaxis, is very important for reducing the mortality of variceal bleeding. Terlipressin and octreotide can effectively control bleeding with few side effects, which has been recommended by Baveno V in treatment of acute variceal bleeding. Terlipressin and high dose octreotide will be administered to the patients with cirrhosis related esophageal varices when they undergo hepatic venous pressure gradient measurement. Changes from portal and systemic hemodynamics will be observed to evaluate the safety and effects of terlipressin and high dose octreotide as well as to determine wether patients respond to them. The results can be served as clinical evidence for preventing re-bleeding through long-acting terlipressin and octreotide in the future.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric and Esophageal Varices have been confirmed through endoscopy
- •Liver Biopsy, CT or MRI indicates cirrhosis
- •Patients who experienced variceal bleeding
排除标准
- •The patients who are beyond the range from 18 to 80 years old
- •The patients with unstable vital signs
- •The patients with spontaneous peritonitis or other severe infections
- •The patients with hepatorenal syndrome or renal inadequacy
- •The patients with uncontrolled hepatic encephalopathy
- •Pregnant and lactating women
- •The patients who had contraindications for terlipressin or octreotide
- •The patients who refuse to take part in this study
研究组 & 干预措施
Terlipressin group
Patients receive terlipressin 2 mg IV bolus
干预措施: Terlipressin (Drug)
High Dose Octreotide group
Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg
干预措施: Octreotide (Drug)
结局指标
主要结局
Fluctuation of HVPG
时间窗: 10min, 20min and 30min after administration
Terlipressin or octreotide will be administered to a patient once after the bottom line of his/her HVPG is determined. We observe the changes of HVPG after administration to find out the effects of terlipressin or octreotide on portal hemodynamics.
次要结局
- Response Rate(10min, 20min and 30min after administration)
研究者
Shiyao Chen
department of Gastroenterology
Shanghai Zhongshan Hospital