Hemodynamic Effects of Terlipressin and High Dose Octreotide

NCT ID: NCT02119884

Last Updated: 2016-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-06-30

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.

Conditions

Gastric and Esophageal Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terlipressin group

Patients receive terlipressin 2 mg IV bolus

Group Type: EXPERIMENTAL

Terlipressin

Intervention Type: DRUG

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

High Dose Octreotide group

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

Group Type: ACTIVE_COMPARATOR

Octreotide

Intervention Type: DRUG

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

Interventions

Terlipressin

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

Intervention Type: DRUG

Octreotide

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

Intervention Type: DRUG

Other Intervention Names

HanWei; ShanNing

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shiyao Chen

department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiyao Chen, Professor

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Locations

180 Fenglin Road

Shanghai, Shanghai Municipality, China

Countries

China

References

Li B, Chen J, Zhang CQ, Wang GC, Hu JH, Luo JJ, Zhang W, Wei YC, Zeng XQ, Chen SY. The pharmacodynamic effect of terlipressin versus high-dose octreotide in reducing hepatic venous pressure gradient: a randomized controlled trial. Ann Transl Med. 2021 May;9(9):793. doi: 10.21037/atm-20-6774.

Reference Type: DERIVED

PMID: 34268406 (View on PubMed)

Other Identifiers

CSY-LB-2014

Identifier Type: -

Identifier Source: org_study_id