| CTRI Number |
CTRI/2024/11/076694 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study on correlation between myocardial dysfunction and heart type fatty acid binding protein in patient of sepsis |
|
Scientific Title of Study
|
A study on association between heart type fatty acid binding protein and myocardial dysfunction in patient of sepsis |
| 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 Pradeep Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Room no 127 1st floor B L Taneja Block Medicine Department Maulana Azad Medical College New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9910555433 |
| Fax |
|
| Email |
pradeepkumar.pacific@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Hans |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana azad medical college and Lok nayak hospital |
| Address |
Ward no 32 Maulana Azad Medical College and Lok Nayak Hospital New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9540353587 |
| Fax |
|
| Email |
mansihans3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Hans |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana azad medical college and Lok nayak hospital |
| Address |
Ward no 32 Maulana Azad Medical College and Lok Nayak Hospital new Delhi
New Delhi
DELHI
110002
India |
| Phone |
9540353587 |
| Fax |
|
| Email |
mansihans3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college |
| Address |
2, Bahardur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government 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 Mansi Hans |
Maulana Azad Medical College and Lok Nayak Hospital New Delhi |
Ward no 32 Maulana Azad Medical College and Lok Nayak Hospital New Delhi
New Delhi
DELHI |
09540353587
mansihans3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I515||Myocardial degeneration, (2) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Routine blood investigations , heart fatty acid binding protein , 2DECHO and relevant radiological investigations |
whole blood and serum sample was analysed only once for routine parameters and heart fatty acid binding protein within 6 hrs of admission |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years admitted with sepsis |
|
| ExclusionCriteria |
| Details |
The evidence of any Cardiac events prior to inclusion (History, Clinical, Electrocardiography, Echocardiography evidence of one of the following - Coronary insufficiency, Endocarditis, Myocarditis or Pericarditis, Rheumatic Heart Disease, Valvular insufficiencies, Cor pulmonale or any form of Cardiomyopathy).
2 The chronic intake of any drug that is known to cause cardiac disease, in the previous 6 months before inclusion (that would include chronic alcoholism, anti-cancer drugs).
3 Patients with systemic disease that are known to influence cardiac function over a long period of time like Diabetes Mellitus, Hypertension, Thyroid disease, HIV disease.
4 Patients in fluid overload state like in Pregnancy, Severe Anaemia . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between heart-type fatty acid binding protein and myocardial dysfunction in patient of sepsis. |
within 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE MYOCARDIAL DYSFUNCTION IN PATIENT OF SEPSIS |
O-72 HOURS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
19/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims at at the assesment of LV function with non-invaise technique in patients of sepsis using echocardiography for detecting structural and functional cardiac abnormalities which are then correlated with levels of heart-type fatty acid binding protein (H-fabp). |