Hemodynamic Effects of Terlipressin and High Dose Octreotide (HEofT&O)

Fudan University

Status and phase: Completed; Phase 4

Conditions: Gastric and Esophageal Varices

Treatments: Drug: Octreotide; Drug: Terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT02119884

CSY-LB-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Terlipressin group

Experimental group

Description:

Patients receive terlipressin 2 mg IV bolus

Treatment:

Drug: Terlipressin

High Dose Octreotide group

Active Comparator group

Description:

Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg

Treatment:

Drug: Octreotide