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

Primary Purpose

Liver Cirrhosis, Portal Hypertension, Variceal Hemorrhage

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Terlipressin

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous infusion of terlipressin

Bolus infusion of terlipressin

Arm Description

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

Traditionally, a bolus infusion of terlipressin is recommended.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Six-week mortality

Death with 6 weeks after treatment

Full Information

NCT ID

NCT03130127

First Posted

April 21, 2017

Last Updated

February 22, 2023

Sponsor

General Hospital of Shenyang Military Region

1. Study Identification

Unique Protocol Identification Number

NCT03130127

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Continuous infusion of terlipressin

Arm Type

Experimental

Arm Description

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

Arm Title

Bolus infusion of terlipressin

Arm Type

Active Comparator

Arm Description

Traditionally, a bolus infusion of terlipressin is recommended.

Intervention Type

Drug

Intervention Name(s)

Terlipressin

Other Intervention Name(s)

Glypressin

Intervention Description

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

Primary Outcome Measure Information:

Title

5 day treatment failure

Description

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.

Time Frame

5 days (120 hours)

Secondary Outcome Measure Information:

Title

Six-week mortality

Description

Death with 6 weeks after treatment

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

Adverse events related to terlipressin [Safety]

Description

Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, etc.

Time Frame

5 days after treatment

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xingshun Qi, MD

Phone

86-18909881019

xingshunqi@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaozhong Guo, MD

Phone

86-024-28897613

guo_xiao_zhong@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaozhong Guo, MD

Organizational Affiliation

General Hospital of Shenyang Military Area

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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