| CTRI Number |
CTRI/2024/06/069001 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the utility of INR to albumin ratio as a predictor of severity in chronic liver disease patients |
|
Scientific Title of Study
|
INR to albumin ratio as a predictor of severity in chronic liver disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Sureddi |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
General Medicine Department, Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8309869656 |
| Fax |
|
| Email |
sureddyvishal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Weena Stanley |
| Designation |
Associate Professor and Head Of Unit |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of General Medicine, Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844111974 |
| Fax |
|
| Email |
weena.stanley@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Weena Stanley |
| Designation |
Associate Professor and Head of Unit |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of General Medicine, Kasturba Hospital Manipal
KARNATAKA
576104
India |
| Phone |
9844111974 |
| Fax |
|
| Email |
weena.stanley@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Udupi, Karnataka, India, 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Vishal Sureddi |
Kasturba Hospital Manipal |
Medicine OPD-A , Second Floor - OPD building , Department of General Medicine , Kasturba Hospital , Manipal
Udupi
KARNATAKA |
8309869656
sureddyvishal@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 - 2 (student research ) |
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 |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosis by ultrasonography (coarse echotexture, increased echogenicity, and nodularity of liver
surface) |
|
| ExclusionCriteria |
| Details |
1) Participants on anticoagulant therapy that could influence INR
2) Chronic kidney disease, which could affect albumin levels
3) Participants with acute liver disease and fulminant hepatic failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The INR to albumin ratio and its association with patients with chronic liver
disease and its severity will be calculated and whether a significant association is found with child Turcotte Pugh and Meld-Na will be calculated. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation between INR to albumin ratio with child Turcotte Pugh score and MELD-Na score |
3 years |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "85"
Final Enrollment numbers achieved (India)="85" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is an observational cross sectional study with an aim to evaluate the utility of INR to albumin ratio as a predictor of severity of chronic liver disease . The subjects admitted to Kasturba Hospital aged 18 years and above with a diagnosis of chronic liver disease based on diagnosis by ultrasonography and clinical evidence of liver dysfunction will be included in the patient group. Patients who meet the inclusion and exclusion criteria will only be recruited for the study. Written and informed consent will be taken from the participants before initiating the study. Information regarding the patient demographics including age , sex , medical history, medications and lifestyles such as smoking status and alcohol consumption will be collected in a data proforma. Laboratory data including liver function tests, renal function tests, and urine microscopy done at admission will be documented. Child Turcotte Pugh score and Meld-Na score is then calculated for each patient along with INR and albumin ratio . The severity of chronic liver disease will be defined based on child Turcotte Pugh score and Meld-Na score . The INR to albumin ratio is then correlated to child Turcotte Pugh score and Meld-Na score. As this study is purely observational, patient management will be chosen by patient’s physicians without any intervention from study investigators. |