To Assess Safety and Efficacy of Bolus Versus Continuous... | NCT02695862

Studies
To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding

NCT02695862

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Completed

Last Update Posted

Sep 4, 2019Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Acute Variceal Bleeding

Interventions

Terlipressin

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2016Actual

Primary Completion Date

Dec 10, 2017Actual

Completion Date

Jan 31, 2018Actual

First Submitted Date

Feb 25, 2016

First Submission Date that Met QC Criteria

Feb 29, 2016

First Posted Date

Mar 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2019

Last Update Posted Date

Sep 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is single centered; prospective, parallel arm randomized controlled trial.The patients will be who presented to Institute of Liver & Biliary Sciences with esophageal variceal bleeding or develop esophageal bleeding during hospital stay. All patients will be managed with continuous non-invasive cardiac and hemodynamic monitoring including cardiac rhythm, pulse rate, blood pressure, and oxygen saturation. Hemoglobin (Hb) will checked every 6 h for the initial 48 h and then every 12 h till discharge. Likewise, serum creatinine will checked daily. Packed red blood cells will be transfused to maintain target Hb of ⩾8 g/dl. Patients will be started on IV Proton Pump Inhibitor, with bolus dose of terlipressin (2mg) followed by Endoscopic variceal ligation. All patients will received prophylactic antibiotics; antibiotics will be stopped if there will no other indication to continue. After confirmation of EVB (Esophageal Variceal Bleeding) and successful initial hemostasis with emergency EVBL (Endoscopic Variceal Band ligation), patients will be randomly assigned into Group -A (Bolus terlipressin at 2mg every 4hourly) and Group-B (Continuous infusion of terlipressin @ 4mg/24hour initially) therapy for esophageal varices . They will then undergo HVPG (Hepatic Venous Pressure Gradient) measurement at baseline, 12hours and 24hours. Patient in continuous group will titrate dose. accordingly to HVPG (Hepatic Venous Pressure Gradient) measurement at 12 and 24 hours. At 24 hours patient will be directed to receive either TIPS (Transjugular Intrahepatic Portosystemic Shunt) or will continue Terlipressin for 48 hours.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bolus Terlipressin	Experimental	Injection terlipressin after 2 mg bolus it will be given 2 mg QID	Drug: Terlipressin
Terlipressin continuous(4mg/24hours)	Active Comparator	Injection terlipressin after 2 mg bolus it will be given 4 mg over 24 hours,and dose will be titrated as per HVPG (Hepatic Venous Pressure Gradient)	Drug: Terlipressin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Terlipressin	Drug		Bolus Terlipressin Terlipressin continuous(4mg/24hours)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of HVPG (hepatic venous pressure gradient) at 24 hours >10%		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Death in both groups		42 days
Terlipressin related complications in both groups		72 hours
Rebleed within 42 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient with only acute esophageal variceal bleeding (as defined by Asian pacific Association for the study of Liver Disease)
Informed consent to participate in the study
Age 18 to 70 years

Exclusion Criteria:

Pregnant and lactation
Prior treatment with any vasoactive drugs
Significant heart or respiratory failure
Peripheral arteriopathy clinically significant
Previous heart stroke or significant alteration of the Electrocardiogram
Hemodynamically unstable
Refusal to participate in the study
Hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Shakti P Choudhury, MD	Institute of Liver and Biliary Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of liver and Biliary Sciences		New Delhi	National Capital Territory of Delhi	110070	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36542261	Derived	Arora V, Choudhary SP, Maiwall R, Vijayaraghavan R, Jindal A, Kumar G, Sarin SK. Low-dose continuous terlipressin infusion is effective and safer than intravenous bolus injections in reducing portal pressure and control of acute variceal bleeding. Hepatol Int. 2023 Feb;17(1):131-138. doi: 10.1007/s12072-022-10416-6. Epub 2022 Dec 21.

ID	Term
D008236	Lypressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones