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Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis

Sponsor
General Hospital of Shenyang Military Region (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03130127
Collaborator
(none)
40
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Continuous infusion of terlipressin

In our clinical practice, continuous infusion of terlipressin is being employed.

Drug: Terlipressin
According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.
Other Names:
  • Glypressin

    		•
    Active Comparator: Bolus infusion of terlipressin

    Traditionally, a bolus infusion of terlipressin is recommended.

    Drug: Terlipressin
    According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.
    Other Names:
  • Glypressin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 5 day treatment failure [5 days (120 hours)]

      Death, fresh hematemesis, hypovolaemic shock, or 3 g drop in Hb (9% drop of Ht) within any 24 h period if no transfusion is administered.

    Secondary Outcome Measures

    1. Six-week mortality [6 weeks]

      Death with 6 weeks after treatment

    Other Outcome Measures

    1. Adverse events related to terlipressin [Safety] [5 days after treatment]

      Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. A diagnosis of liver cirrhosis;

    2. Child-Pugh B or C;

    3. Acute gastroesophageal variceal bleeding;

    4. Written informed consents. -

    Exclusion Criteria:

    1. No liver cirrhosis;

    2. Child-Pugh class A;

    3. Acute upper gastrointestinal bleeding unrelated to varices;

    4. Use of somatostatin or octreotide. -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • General Hospital of Shenyang Military Region

    Investigators

    • Principal Investigator: Xiaozhong Guo, MD, General Hospital of Shenyang Military Area

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xingshun Qi, Doctor, General Hospital of Shenyang Military Region
    ClinicalTrials.gov Identifier:
    NCT03130127
    Other Study ID Numbers:
    • TERLIPRESSIN-LC
    First Posted:
    Apr 26, 2017
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Hypertension, Portal
    Esophageal and Gastric Varices
    Hypertension
    Hemorrhage
    Fibrosis
    Terlipressin

    Study Results

    No Results Posted as of Mar 18, 2022