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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Terlipressin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of liver cirrhosis; Child-Pugh B or C; Acute gastroesophageal variceal bleeding; Written informed consents. - Exclusion Criteria: No liver cirrhosis; Child-Pugh class A; Acute upper gastrointestinal bleeding unrelated to varices; Use of somatostatin or octreotide. -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous infusion of terlipressin<br>In our clinical practice, continuous infusion of terlipressin is being employed. | Drug: Terlipressin<br>* According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.<br>* Other names: Glypressin;|
| Active Comparator: Bolus infusion of terlipressin<br>Traditionally, a bolus infusion of terlipressin is recommended. | Drug: Terlipressin<br>* According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.<br>* Other names: Glypressin;|

What is the study measuring?
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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 |