| CTRI Number |
CTRI/2018/02/011992 [Registered on: 20/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Terlipressin (drug) in Acute Variceal Bleeding (Liver Disease). |
|
Scientific Title of Study
|
A randomized open label study to Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol version 2017 |
Protocol Number |
| NCT02695862 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shakti P Choudhary |
| Designation |
Senior Resident, Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No 1042,First Floor,
Department of Hepatology,
D-1,Vasant Kunj,
New Delhi
New Delhi
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
shakti784@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Kumar Sarin |
| Designation |
Senior Professor, Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No 1042,First Floor,
Department of Hepatology,
D-1,Vasant Kunj,
New Delhi
New Delhi
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
shivsarin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shakti P Choudhury |
| Designation |
Senior Resident, Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No 1042,First Floor,
Department of Hepatology,
D-1,Vasant Kunj,
New Delhi
New Delhi
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
shakti784@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences
D-1, Vasant Kunj
New Delhi-110070 |
|
|
Primary Sponsor
|
| Name |
Institute of liver and Biliary Sciences |
| Address |
D-1,Vasant Kunj |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shakti P Choudhury |
Institute of Liver and Biliary Science |
Room No 1042,First Floor,
Department of Hepatology,
D-1,Vasant Kunj
New Delhi
New Delhi
DELHI |
01146300000
01146300025
shakti784@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute variceal bleed, (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bolus Terlipressin |
Injection terlipressin after 2 mg bolus it will be given 1 mg QID |
| Comparator Agent |
Terlipressin continuous(4mg/24hours) |
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) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Any patient with only acute esophageal variceal bleeding (as defined by Asian pacific Association for the study of Liver Disease)
2) Informed consent to participate in the study
3) Age 18 to 70 years
|
|
| ExclusionCriteria |
| Details |
1) Pregnant and lactation
2) Prior treatment with any vasoactive drugs
3) Significant heart or respiratory failure
4) Peripheral arteriopathy clinically significant
5) Previous heart stroke or significant alteration of the Electrocardiogram
6) Hemodynamically unstable
7) Refusal to participate in the study
8) Hypertension
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Re bleeding in both group |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Death in both groups |
2 Years |
| Terlipressin related complications in both groups |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2016 |
| Date of Study Completion (India) |
31/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 1mg 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. |