Hemodynamic Effects of Terlipressin and High Dose Octreotide (HEofT&O)
Primary Purpose
Gastric and Esophageal Varices
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Terlipressin
Octreotide
Sponsored by
About this trial
This is an interventional treatment trial for Gastric and Esophageal Varices focused on measuring Gastric and Esophageal Varices, Hepatic Venous Pressure Gradient, Terlipressin, Octreotide
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
Sites / Locations
- 180 Fenglin Road
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Terlipressin group
High Dose Octreotide group
Arm Description
Patients receive terlipressin 2 mg IV bolus
Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Response Rate
Patients are considered responders when the HVPG decreases below 20 mmHg or by more than 10% from the baseline value
Full Information
NCT ID
NCT02119884
First Posted
April 17, 2014
Last Updated
June 9, 2016
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shandong Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02119884
Brief Title
Hemodynamic Effects of Terlipressin and High Dose Octreotide
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shandong Provincial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric and Esophageal Varices
Keywords
Gastric and Esophageal Varices, Hepatic Venous Pressure Gradient, Terlipressin, Octreotide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Terlipressin group
Arm Type
Experimental
Arm Description
Patients receive terlipressin 2 mg IV bolus
Arm Title
High Dose Octreotide group
Arm Type
Active Comparator
Arm Description
Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Other Intervention Name(s)
HanWei
Intervention Description
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
Intervention Name(s)
Octreotide
Other Intervention Name(s)
ShanNing
Intervention Description
Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.
Primary Outcome Measure Information:
Title
Fluctuation of HVPG
Description
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.
Time Frame
10min, 20min and 30min after administration
Secondary Outcome Measure Information:
Title
Response Rate
Description
Patients are considered responders when the HVPG decreases below 20 mmHg or by more than 10% from the baseline value
Time Frame
10min, 20min and 30min after administration
Other Pre-specified Outcome Measures:
Title
Fluctuation of MAP and HR
Description
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.
Time Frame
10min, 20min and 30min after administration
Title
Incidence rate of complications
Description
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.
Time Frame
Participants will be followed for up to 24h starting from the moment of administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, Professor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34268406
Citation
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.
Results Reference
derived
Learn more about this trial
Hemodynamic Effects of Terlipressin and High Dose Octreotide
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