| CTRI Number |
CTRI/2024/03/064273 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Carvedilol drug in ACLF Patients (liver disease). |
|
Scientific Title of Study
|
Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients –“ACT - C ACLF study†|
| Trial Acronym |
ACT - C ACLF Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garvit Mundra |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3352, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
garvitmundra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitranshu vashishtha |
| Designation |
Associate Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3352, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070.
kunj
South West
DELHI
110070
India |
| Phone |
09540951042 |
| Fax |
|
| Email |
chitranshuv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitranshu vashishtha |
| Designation |
Associate Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3352, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070.
kunj
South West
DELHI
110070
India |
| Phone |
09540951042 |
| Fax |
|
| Email |
chitranshuv@gmail.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 |
Room No. 3352, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, 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 Garvit Mundra |
Institute of Liver and Biliary Sciences |
Room No. 3352, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
garvitmundra@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: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18–70 yrs
2. ACLF diagnosis (AARC criteria)
|
|
| ExclusionCriteria |
| Details |
1. Contraindications to NSBB (Heart rate less than 65 per min, BP less than 110 by 65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na less than 125)
2. PVT
3. HCC
4. BCS
5. HE grades 2 to 4
6. NSBB therapy within 5 days
7. Pregnancy
8. Lactation
9. Planned for LT in the next 12 weeks
10. No consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF |
Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days |
90 days |
| Transplant-free survival rate at 90 days |
90 days |
| Correlation with evolution of AARC score by 2 weeks |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2024 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Clinically significant
portal hypertension (CSPH) is defined asHVPG >10 mmHg. Patients with CSPH are at risk of developing
esophageal varices and clinical decompensation (variceal bleeding,
ascites,jaundice, encephalopathy), which mark the transition from compensated
stage to a stage of the disease (decompensated) associated with higher
mortality(1). HVPG is calculated by subtracting the free hepatic venous
pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous
pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate
marker in many clinical applications such as gold standard test to evaluate
presence and severity of portal hypertension (PHT) diagnosis, risk
stratification, monitoring of the patients on beta blockers(2). Non selective beta-blockers like propranolol
and carvedilol are indicated in adults for primary and secondary prophylaxis of
varicealhemorrhage. Acute hemodynamic response to intravenous propranolol with
HVPG values coming down to <12 mm Hg or reduction to >20% from baseline have
been shown to be associated with reduced long term risk of variceal bleed.Hence
we are planning the current work to study the Acute hemodynamiC response To
Carvedilol predicts survival in ACLF patients – “ACT - C ACLF study. |