| CTRI Number |
CTRI/2025/02/080135 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Terlipressin (drug) in liver disease. |
|
Scientific Title of Study
|
Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed -Pilot Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khushboo Yadav |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
ky29277@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Arora |
| Designation |
Associate Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
VINOD_UCMS@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Arora |
| Designation |
Associate Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
VINOD_UCMS@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant kunj, New Delhi-110070. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1,Vasant kunj, New Delhi-110070. |
| 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 Khushboo Yadav |
Institute of Liver and Biliary Sciences |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
ky29277@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus terlipressin |
2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs. |
| Intervention |
Continous Infusion of Terlipressin |
Administered as a continuous infusion at 4 mg per 24 hours. After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg per 24 hours.
Route: Intravenous |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (age more than equals to 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding. |
|
| ExclusionCriteria |
| Details |
1. History of coronary heart disease or ventricular arrhythmia,
2. Stroke or transient ischemic attack,
3. Bronchial asthma,
4. Epilepsy,
5. Pregnancy,
6. Rebleeding.
7. HCC
8. Gastric variceal bleed
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HVPG responder at 12-24 hours in both arms |
12-24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Failure to control hemostasis |
5 days |
| Terlipressin-related complications within 5 days i.e. safety of the drug |
5 days |
| Number of blood transfusions at 5 days |
5 days |
| Rebleed within 42 day. |
42 days |
| Incidence of post-bleed AKI within 5 days. |
5 days |
| 6 weeks mortality in both groups |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB) AVB: 6-week mortality rates of around 15–20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide. Aim and Objective – To assess the safety and efficacy of continuous terlipressin vs. Bolus terlipressin in the management of acute esophageal variceal bleeding in ACLF. Study population: Adult patients diagnosed with ACLF presenting with upper GI bleeding due to esophageal varices. Study design: Pilot study Study period: 1 year Sample size: 60 Intervention: Group I- Intravenous terlipressin (administered as a continuous infusion at 4 mg per 24 hours). After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg per 24 hours.
Group II- Intravenous terlipressin (2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs)
Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid
Adverse effects: Acute Diarrhea, chest pain, Arterial hypertension, Cardiac arrhythmias, Acute abdomen Stopping rule: chest pain, alteration of ECG, cyanosis, bradycardia, severe allergic rashes
|