Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,320
- 试验地点
- 1
- 主要终点
- The Change of Rebleeding Rate
研究概览
简要总结
To observe and access the Effects and safety of terlipressin or high dose somatostatin/octreotide when usual dose somatostatin/octreotide fail to achieve hemostasis in patients with acute variceal bleeding.
详细描述
The prognosis information of the patients with acute variceal bleeding will be collected, including hemostasis rate, early rebleeding rate, mortality, complications, severity adverse events, economic burdens and quality of life, when terlipressin or high dose somatostatin/octreotide is used as salvation to patients fail to achieve initial hemostasis.The results may help gastroenterologists to make decisions when administering vasoactive medicines to those suffered from acute variceal bleeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding
排除标准
- •No signs of variceal bleeding are found by endoscopy or portal hypertensive gastropathy is responsible for the bleeding
- •Patients undergo endoscopy after 72h from the beginning of acute variceal bleeding
- •Patients with hepatorenal syndrome
- •Patients with ischemia organic cardiopathy (including myocardial infarction or unstable angina pectoris) or myocardial ischemia indicated by ECG in the past 6 months
- •Patients allergic to/with contraindications of vasoactive drugs
研究组 & 干预措施
High Dose Somatostatin/Octreotide
continuous IV infusion of 500μg/h of Somatostatin or continuous IV infusion of 50μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
干预措施: Usual Dose Somatostatin/Octreotide (Drug)
High Dose Somatostatin/Octreotide
continuous IV infusion of 500μg/h of Somatostatin or continuous IV infusion of 50μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
干预措施: High Dose Somatostatin/Octreotide (Drug)
Terlipressin as salvage
an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
干预措施: Terlipressin (Drug)
Terlipressin as salvage
an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
干预措施: Usual Dose Somatostatin/Octreotide (Drug)
Terlipr+usual dose somato/Octreo
an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h together with continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
干预措施: Terlipressin (Drug)
Terlipr+usual dose somato/Octreo
an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h together with continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
干预措施: Usual Dose Somatostatin/Octreotide (Drug)
Terlipr+usual dose somato/Octreo
an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h together with continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients
干预措施: High Dose Somatostatin/Octreotide (Drug)
Control:Usual Dose Somato/Octreo
Hemostasis achieved by continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide
干预措施: Usual Dose Somatostatin/Octreotide (Drug)
Control: Initial Terlipressin
Hemostasis achieved by an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h
干预措施: Terlipressin (Drug)
结局指标
主要结局
The Change of Rebleeding Rate
时间窗: 1month, 3months, 6 months, 12 months
次要结局
- The Change of Survival Rate(1month, 3months, 6 months, 12 months)
- Economic Cost(up to 12 months)
- The Change of Quality of Life(1month, 3months, 6 months, 12 months)
- The Change of Complication Rate(1month, 3months, 6 months, 12 months)
- The Change of Drug Adverse Reaction Rate(1month, 3months, 6 months, 12 months)
研究者
Shiyao Chen
Director of department fo Gastroenterology, Zhongshan Hospital
Shanghai Zhongshan Hospital