Hemodynamic Effects of Terlipressin and High Dose Octreotide

Phase 4CompletedNCT02119884

Shanghai Zhongshan Hospital88 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric and Esophageal Varices

Interventions

TerlipressinDRUG

Patients in the terlipressin group receive a single IV injection of 2 mg of terlipressin and a continuous IV infusion of normal saline.

OctreotideDRUG

Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 10min, 20min and 30min after administration

Secondary Outcomes

Response Rate

Patients are considered responders when the HVPG decreases below 20 mmHg or by more than 10% from the baseline value

Time frame: 10min, 20min and 30min after administration

Data from ClinicalTrials.gov

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