Clinical Trial: Hemodynamic Effects of Terlipressin and High Dose Octreotide

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome: Fluctuation of HVPG [ Time Frame: 10min, 20min and 30min after administration ]

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.


Original Primary Outcome: Fluctuation of HVPG [ Time Frame: 10 min and 20 min after administration ]

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.


Current Secondary Outcome: Response Rate [ Time Frame: 10min, 20min and 30min after administration ]

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


Original Secondary Outcome: Response Rate [ Time Frame: 20 min after administration ]

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


Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: April 17, 2014
Date Started: February 2014
Date Completion:
Last Updated: June 9, 2016
Last Verified: June 2016