RCT for the Effect of Early Administration of Vasoactive Substances When Combined With Endoscopic Treatment in Acute Gastro-esophageal Variceal Bleeds: Comparisons Among Terlipressin, Somatostatin, and Octreotide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,034
- 试验地点
- 1
- 主要终点
- 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
研究概览
简要总结
This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.
详细描述
In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver cirrhosis
- •age between 16 and 75 years
- •Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment
- •Patients whose systolic blood pressure <100 mmHg or pulse rate >100/min at the enrollment
- •Patients who were not performed endoscopic or pharmacologic therapy for varices
- •Signed informed consent
排除标准
- •Pregnancy
- •Positive anti-HIV Ab
- •A history of severe side-effects or contraindications to study drugs
- •Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure >170 mmHg or diastolic pressure >100 mmHg)
- •Chronic renal failure
- •Hepatocellular carcinoma with protal vein thrombosis
- •Coexisting malignancy except hepatocellular carcinoma
研究组 & 干预措施
Terlipressin
treat with terlipressin IV for 5 days and endoscopic treatment
干预措施: Terlipressin (Drug)
Somatostatin
treat with somatostatin IV for 5 days and endoscopic treatment
干预措施: Somatostatin (Drug)
Octreotide
treat with octreotide IV for 5 days and endoscopic treatment
干预措施: Octreotide (Drug)
结局指标
主要结局
5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
时间窗: 5 days after enrollment
次要结局
- Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects(5 days after enrollment)