Hemodynamic Effects of Terlipressin and High Dose Octreotide (HEofT&O)

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric and Esophageal Varices
• Intervention / Treatment: Drug: Terlipressin; Drug: Octreotide

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Terlipressin group; Patients receive terlipressin 2 mg IV bolus	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.; Other Names: HanWei
Active Comparator: High Dose Octreotide group; Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg	Drug: Octreotide; Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.; Other Names: ShanNing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shandong Provincial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: April 21, 2014
• First Posted (Estimate): April 22, 2014

Study Record Updates

• Last Update Posted (Estimate): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Octreotide; Terlipressin; Hepatic Venous Pressure Gradient; Gastric and Esophageal Varices
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices; Antihypertensive Agents; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Vasoconstrictor Agents; Octreotide; Terlipressin
• Other Study ID Numbers: CSY-LB-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No