Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding

Conditions
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Liver Cirrhosis, Esophageal and Gastric Varices, Hemorrhage

Intervention / Treatment
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* Drug: Terlipressin
* Drug: Usual Dose Somatostatin/Octreotide
* Drug: High Dose Somatostatin/Octreotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Dose Somatostatin/Octreotide<br>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 | Drug: Usual Dose Somatostatin/Octreotide<br>* administered as a first-line medicine or as salvage<br>* Other names: Yisuo/Shanning;Drug: High Dose Somatostatin/Octreotide<br>* administered as salvage<br>* Other names: Yisuo/Shanning;|
| Terlipressin as salvage<br>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 | Drug: Terlipressin<br>* administered as a first-line medicine or as salvage<br>* Other names: Hanwei;Drug: Usual Dose Somatostatin/Octreotide<br>* administered as a first-line medicine or as salvage<br>* Other names: Yisuo/Shanning;|
| Terlipr+usual dose somato/Octreo<br>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 | Drug: Terlipressin<br>* administered as a first-line medicine or as salvage<br>* Other names: Hanwei;Drug: Usual Dose Somatostatin/Octreotide<br>* administered as a first-line medicine or as salvage<br>* Other names: Yisuo/Shanning;Drug: High Dose Somatostatin/Octreotide<br>* administered as salvage<br>* Other names: Yisuo/Shanning;|
| Control:Usual Dose Somato/Octreo<br>Hemostasis achieved by continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide | Drug: Usual Dose Somatostatin/Octreotide<br>* administered as a first-line medicine or as salvage<br>* Other names: Yisuo/Shanning;|
| Control: Initial Terlipressin<br>Hemostasis achieved by an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h | Drug: Terlipressin<br>* administered as a first-line medicine or as salvage<br>* Other names: Hanwei;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of Rebleeding Rate |  | 1month, 3months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic Cost |  | up to 12 months | 
| The Change of Quality of Life |  | 1month, 3months, 6 months, 12 months | 
| The Change of Survival Rate |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute variceal hemorrhage, terlipressin, somatostatin, octreotide, comparative effectiveness research