Hemodynamic Effects of Terlipressin and High Dose Octreotide

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hemodynamic Effects of Terlipressin and High Dose Octreotide on Patients With Liver Cirrhosis Related Esophageal Varices: A Randomized, Placebo-controlled Multicenter Trial

Conditions
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Gastric and Esophageal Varices

Intervention / Treatment
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* Drug: Terlipressin
* Drug: Octreotide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terlipressin group<br>Patients receive terlipressin 2 mg IV bolus | Drug: Terlipressin<br>* Patients in the terlipressin group receive a single IV injection of 2 mg of terlipressin and a continuous IV infusion of normal saline.<br>* Other names: HanWei;|
| Active Comparator: High Dose Octreotide group<br>Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg | Drug: Octreotide<br>* Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.<br>* Other names: ShanNing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluctuation of HVPG | 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. | 10min, 20min and 30min after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Patients are considered responders when the HVPG decreases below 20 mmHg or by more than 10% from the baseline value | 10min, 20min and 30min after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric and Esophageal Varices, Hepatic Venous Pressure Gradient, Terlipressin, Octreotide