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

NCT03130127 | Not Yet Recruiting

• 1 other identifier: TERLIPRESSIN-LC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Cirrhosis; Portal Hypertension; Variceal Hemorrhage; Bleeding; Esophageal and Gastric Varices

Outcome Measures

Primary Outcomes (1)

• 5 day treatment failure

  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.

  5 days (120 hours)

Secondary Outcomes (1)

• Six-week mortality

  6 weeks

Other Outcomes (1)

• Adverse events related to terlipressin [Safety]

  5 days after treatment

Study Arms (2)

Continuous infusion of terlipressin

EXPERIMENTAL

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

Drug: Terlipressin

Bolus infusion of terlipressin

ACTIVE COMPARATOR

Traditionally, a bolus infusion of terlipressin is recommended.

Drug: Terlipressin

Interventions

Terlipressin DRUG

According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.

Also known as: Glypressin

Bolus infusion of terlipressin; Continuous infusion of terlipressin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of liver cirrhosis;
• Child-Pugh B or C;
• Acute gastroesophageal variceal bleeding;
• Written informed consents. -

You may not qualify if:

• No liver cirrhosis;
• Child-Pugh class A;
• Acute upper gastrointestinal bleeding unrelated to varices;
• Use of somatostatin or octreotide. -

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Hemorrhage; Esophageal and Gastric Varices

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Xiaozhong Guo, MD

  General Hospital of Shenyang Military Area

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingshun Qi, MD

CONTACT

86-18909881019; xingshunqi@126.com

Xiaozhong Guo, MD

CONTACT

86-024-28897613; guo_xiao_zhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 26, 2017
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share