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Trial · Interventional

CompletedPhase 4Registry data

Hemodynamic Effects of Terlipressin and High Dose Octreotide

Short name HEofT&O

NCTNCT02119884 (opens ClinicalTrials.gov in a new tab)Other idCSY-LB-2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
88 participants (actual)
Sponsor
Shanghai Zhongshan Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Feb 2014
Primary completion
Jun 2016
Completion
Jun 2016
First posted
22 Apr 2014 (estimated)
Last update posted
13 Jun 2016 (estimated)
Conditions
Gastric and Esophageal Varices

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 4

    HEofT&O

    NCT02119884

    Feb 2014 to Jun 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TerlipressinDrug
  • OctreotideDrug

Arms2

  • Experimental

    Terlipressin group

    Patients receive terlipressin 2 mg IV bolus

  • Active comparator

    High Dose Octreotide group

    Patients receive Octreotide 50 μg/h with an initial bolus of 100 μg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Fluctuation of HVPG

    Time frame · 10min, 20min and 30min after administration

    Registry 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.

Secondary outcomes(1)

  1. Response Rate

    Time frame · 10min, 20min and 30min after administration

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2021

The pharmacodynamic effect of terlipressin versus high-dose octreotide in reducing hepatic venous pressure gradient: a randomized controlled trial.

Li et al. 2021Annals of translational medicinecited by 9

PMID 34268406PMC8246168DOI 10.21037/atm-20-6774PUB-34268406

Free to read · publisher termsCC BY-NC-ND
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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