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

Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis; Bleeding; Esophageal and Gastric Varices; Portal Hypertension; Variceal Hemorrhage
• Intervention / Treatment: Drug: Terlipressin

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingshun Qi, MD; Phone Number: 86-18909881019; Email: xingshunqi@126.com
• Study Contact Backup: Name: Xiaozhong Guo, MD; Phone Number: 86-024-28897613; Email: guo_xiao_zhong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-week mortality	Death with 6 weeks after treatment	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to terlipressin [Safety]	Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, etc.	5 days after treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Fibrosis; Hypertension; Hemorrhage; Liver Cirrhosis; Esophageal and Gastric Varices; Hypertension, Portal; Antihypertensive Agents; Vasoconstrictor Agents; Terlipressin
• Other Study ID Numbers: TERLIPRESSIN-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No