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

Not Applicable

Not yet recruiting

• Conditions: Portal Hypertension; Variceal Hemorrhage; Bleeding; Liver Cirrhosis; Esophageal and Gastric Varices
• Interventions: Drug: Terlipressin

• Registration Number: NCT03130127
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

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 Timeline

• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Study Start: 2024-07-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion of terlipressin	Terlipressin	In our clinical practice, continuous infusion of terlipressin is being employed.
Bolus infusion of terlipressin	Terlipressin	Traditionally, a bolus infusion of terlipressin is recommended.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Six-week mortality	6 weeks	Death with 6 weeks after treatment