Hemodynamic Effects of Terlipressin and High Dose Octreotide

Gastric and Esophageal Varices Clinical Trial

— HEofT&O  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119884
• Other study ID #: CSY-LB-2014
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2014
• Last updated: June 9, 2016
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric and Esophageal Varices

Intervention

Drug:
• Terlipressin
Patients in the terlipressin group receive a single IV injection of 2 mg of terlipressin and a continuous IV infusion of normal saline.
• Octreotide
Patients in high dose octreotide receive a single injection of 100µg octreotide and continuous IV infusion of 50 µg/h of octreotide.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fluctuation of MAP and HR	Terlipressin or octreotide will be administered to a patient once after the bottom line of his/her mean arterial pressure and heart rate, as well as HVPG, are determined. We observe the changes of MAP and HR after administration to find out the effects of terlipressin or octreotide on systemic hemodynamics.	10min, 20min and 30min after administration
Other	Incidence rate of complications	We intend to set incidence rate of complications associated with terlipressin or octreotide, to be specific, which include hypertension, abdominal pain, nausea, vomiting, diarrhea, headache, transient arrhythmia and vertigo. Participants will be followed for up to 24h starting from the moment of administration.	Participants will be followed for up to 24h starting from the moment of administration
Primary	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	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