| CTRI Number |
CTRI/2025/01/079246 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check MELD 3.0 and MELD-Na for predicting mortality in patients with liver cirrhosis |
|
Scientific Title of Study
|
Model for end-stage liver disease-3.0 and model for end-stage liver
disease-sodium in predicting mortality in cirrhosis- A comparative study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ganesh Bhat |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College |
| Address |
Department of gastroenterology and hepatology, kasturba medical college, manipal academy of higher education,
Udupi
KARNATAKA
576104
India |
| Phone |
9900791615 |
| Fax |
|
| Email |
bhat.ganesh@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Bhat |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College |
| Address |
Department of gastroenterology and hepatology, kasturba medical college, manipal academy of higher education,
Udupi
KARNATAKA
576104
India |
| Phone |
9900791615 |
| Fax |
|
| Email |
bhat.ganesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sriman Narayan Reddy |
| Designation |
DM Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of gastroenterology and hepatology, kasturba medical college, manipal academy of higher education,
Udupi
KARNATAKA
576104
India |
| Phone |
9000488883 |
| Fax |
|
| Email |
sriman.narayn2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| kasturba medical college, manipal academy of higher education, manipal, karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [NIL] |
|
|
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 Sriman narayan reddy |
Kasturba medical college |
New Block OPD, 4th floor,Department of Gastroenterology and Hepatology
Udupi
KARNATAKA |
9000488883
sriman.narayan2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age of 18 and above, irrespective of gender.
Patients diagnosed with liver cirrhosis and clinically significant portal hypertension based
on clinical, radiological, and biochemical parameters. |
|
| ExclusionCriteria |
| Details |
ACLF
Ischemic hepatitis
Hepatocellular carcinoma
Any extrahepatic malignancy with a life expectancy of less than 3 months
Any severe extrahepatic disease that has an impact on survival of less than 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare MELD-Na and MELD 3.0 in predicting the 30 days and 90 days mortality, liver transplantation and death in patients with cirrhosis |
0, 28 and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gender specific mortality and etiology specific mortality prediction using MELD-Na and MELD-3.0 scores. |
0, 28 and 90 days |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
03/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
After obtaining written informed consent and checking for exclusion criteria, patients with cirrhosis will be enrolled in the study. Information regarding relevant History, physical examination, demographic and laboratory parameters will be entered in a preformatted data sheet. S. albumin, S. sodium, S. creatinine, INR, Sex of the study participant, S. bilirubin will be used to calculate MELD, MELD-Na, MELD 3.0 scores. Patients will be followed for 3 months mortality or liver transplantation. |