Hemodynamic Effects of Terlipressin and High Dose Octreotide

Phase 4

Completed

• Conditions: Gastric and Esophageal Varices
• Interventions: Drug: Terlipressin; Drug: Octreotide

• Registration Number: NCT02119884
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-22
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Gastric and Esophageal Varices have been confirmed through endoscopy
• Liver Biopsy, CT or MRI indicates cirrhosis
• Patients who experienced variceal bleeding

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terlipressin group	Terlipressin	Patients receive terlipressin 2 mg IV bolus
High Dose Octreotide group	Octreotide	Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg

Primary Outcome Measures

Name	Time	Method
Fluctuation of HVPG	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.

Secondary Outcome Measures

Name	Time	Method
Response Rate	10min, 20min and 30min after administration	Patients are considered responders when the HVPG decreases below 20 mmHg or by more than 10% from the baseline value

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China