Hemodynamic Effects of Terlipressin and High Dose Octreotide (HEofT&O)
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|ClinicalTrials.gov Identifier: NCT02119884|
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : June 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastric and Esophageal Varices||Drug: Terlipressin Drug: Octreotide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hemodynamic Effects of Terlipressin and High Dose Octreotide on Patients With Liver Cirrhosis Related Esophageal Varices: A Randomized, Placebo-controlled Multicenter Trial|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Terlipressin group
Patients receive terlipressin 2 mg IV bolus
Patients in the terlipressin group receive a single IV injection of 2 mg of terlipressin and a continuous IV infusion of normal saline.
Other Name: HanWei
Active Comparator: High Dose Octreotide group
Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg
Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.
Other Name: ShanNing
- 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.
- 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
- Fluctuation of MAP and HR [ 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 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.
- Incidence rate of complications [ Time Frame: Participants will be followed for up to 24h starting from the moment of administration ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119884
|180 Fenglin Road|
|Shanghai, Shanghai, China, 200032|
|Study Director:||Shiyao Chen, Professor||Shanghai Zhongshan Hospital|