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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
Sponsor:
Collaborator:
Shandong Provincial Hospital
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric and Esophageal Varices Drug: Terlipressin Drug: Octreotide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


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 Name: 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 Name: ShanNing




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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China, Shanghai
180 Fenglin Road
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Shandong Provincial Hospital
Investigators
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Study Director: Shiyao Chen, Professor Shanghai Zhongshan Hospital

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Responsible Party: Shiyao Chen, department of Gastroenterology, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02119884     History of Changes
Other Study ID Numbers: CSY-LB-2014
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:
Gastric and Esophageal Varices
Hepatic Venous Pressure Gradient
Terlipressin
Octreotide
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Octreotide
Terlipressin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antihypertensive Agents
Vasoconstrictor Agents