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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03130127
• Other study ID #: TERLIPRESSIN-LC
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: General Hospital of Shenyang Military Region
• Contact: Xingshun Qi, MD
• Phone: 86-18909881019
• Email: xingshunqi[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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. -

Related Conditions & MeSH terms

• Bleeding
• Esophageal and Gastric Varices
• Fibrosis
• Hemorrhage
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension
• Variceal Hemorrhage

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events related to terlipressin [Safety]	Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, etc.	5 days after treatment
Primary	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	Six-week mortality	Death with 6 weeks after treatment	6 weeks