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Completed

NCT Number: NCT02119884

Hemodynamic Effects of Terlipressin and High Dose Octreotide

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.

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Key information

Conditions

Gastric and Esophageal Varices Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terlipressin

Drug

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

Octreotide

Drug

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Shandong Provincial Hospital

Registry information

Official study title

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

Acronym: HEofT&O

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2014
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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