| CTRI Number |
CTRI/2024/03/063706 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mortality predictor in Acute on Chronic liver failure |
|
Scientific Title of Study
|
Clinical Profile of Acute on Chronic Liver Failure and Chronic Liver Failure Consortium Acute on Chronic Liver Failure (CLIF C ACLF) score as a predictor of its short-term mortality |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amar Minda |
| Designation |
Junior Resident Department of General Medicine |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine, second-floor OPD block, Kasturba Medical College, Manipal, Karnataka, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9593946686 |
| Fax |
|
| Email |
amarminda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Bhat |
| Designation |
Associate Professor, Medicine Department |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine, second-floor OPD block, Kasturba Medical College, Manipal, Karnataka, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9008576103 |
| Fax |
|
| Email |
nitin.k.bhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanchit Mittal |
| Designation |
Junior Resident Department of General Medicine |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine, second-floor OPD block, Kasturba Medical College, Manipal, Karnataka, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8595289133 |
| Fax |
|
| Email |
sanchitmittal29@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Amar Minda |
| Address |
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Amar Minda |
Kasturba Hospital, Manipal |
Kasturba Hospital Manipal, Department of General Medicine
Udupi
KARNATAKA |
9593946686
amarminda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital I Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K720||Acute and subacute hepatic failure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders aged more than 18 years with the diagnosis of ACLF according to the EASL CLIF definition. |
|
| ExclusionCriteria |
| Details |
1. Previously diagnosed Hepatocellular carcinoma
2. Have severe chronic extrahepatic disease
3. Retro positive
4. Patient on immunosuppressive drugs
5. Acute CVA
6. Acute MI
7. Orthotopic liver transplantation during follow-
up
8. Pregnant females
9. Those who are not willing to participate in the
study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for 28 day mortality, in hospital mortality and duration of ICU stay among various grades of CLIF C-ACLF |
at 48 hours and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
01/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
NEED FOR THE STUDY It is very important to stratify patients according to prognosis, monitor treatment responsiveness, determine emergency for transplantation, decide allocation in the intensive care unit (ICU), and have a rational basis to decide futility. Despite this catastrophic presentation and outcome, there is a component of potential reversibility with adequate support and management of the precipitating factor. Although several lines of evidence demonstrate that CLIF C ACLF prognostic score is superior to the conventional prognostic scores for the estimation of prognosis in these patients, the optimum score with the highest performance has not been enough explored yet, especially in India. A universally accepted prognostic model for ACLF is lacking due to discrepancies and unevenness in the definition of ACLF.
DESCRIPTION Patients will be selected based on the above criteria and recruited into the study after taking informed written consent, confidentiality will be maintained. Demographic and clinical data of every patient with ACLF including age, gender, and BMI will be recorded in a data Proforma. Laboratory data including complete blood count, renal function and liver function tests, coagulation profile, and arterial blood gas analysis done at 48 hours of admission will be documented. CLIF C ACLF score will be calculated and patients will be categorized into various grades of CLIF C ACLF. Clinical outcomes will be assessed by: 1) 28-day mortality, 2) in-hospital mortality, and 3) duration of ICU/ HDU stay among various grades of CLIF C AClF. As this study is purely observational, patient management and antimicrobial therapy will be chosen by patients’ physicians without any intervention from study investigators. |