Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails

• Conditions: Esophageal and Gastric Varices; Liver Cirrhosis; Hemorrhage
• Interventions: Drug: Usual Dose Somatostatin/Octreotide; Drug: Terlipressin; Drug: High Dose Somatostatin/Octreotide

• Registration Number: NCT02311608
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-11-26
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-05
• Last Update Submitted: 2014-12-05
• Study First Posted: 2014-12-08
• Last Update Posted: 2014-12-08
• Primary Completion: 2016-02
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Dose Somatostatin/Octreotide	Usual 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
Control:Usual Dose Somato/Octreo	Usual Dose Somatostatin/Octreotide	Hemostasis achieved by continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide
High Dose Somatostatin/Octreotide	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
Terlipr+usual dose somato/Octreo	High Dose Somatostatin/Octreotide	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
Terlipressin as salvage	Usual Dose Somatostatin/Octreotide	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
Terlipr+usual dose somato/Octreo	Usual Dose Somatostatin/Octreotide	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
Terlipressin as salvage	Terlipressin	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
Terlipr+usual dose somato/Octreo	Terlipressin	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
Control: Initial Terlipressin	Terlipressin	Hemostasis achieved by an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h

Primary Outcome Measures

Name	Time	Method
The Change of Rebleeding Rate	1month, 3months, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China