| CTRI Number |
CTRI/2024/06/069419 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Different Categories of Heart Abnormalities in Severe Infection |
|
Scientific Title of Study
|
A Study of Cardiac Phenotypes in 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 |
Rajika Khanna |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar,Manipal
Manipal Academy Of Higher Education,Madhav Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7022889430 |
| Fax |
|
| Email |
rajikakhanna2309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath H Hande |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal, Karnataka, India
Manipal Academy Of Higher Education,Madhav Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9972597655 |
| Fax |
|
| Email |
manjunath.hande@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath H Hande |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar,Manipal
Manipal Academy Of Higher Education,Madhav Nagar,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9972597655 |
| Fax |
|
| Email |
manjunath.hande@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department Of General Medicine,Kasturba Medical College,Madhav Nagar, Manipal,Karnataka,India,Pin code-576104 |
|
|
Primary Sponsor
|
| Name |
Katurba Medical College Manipal |
| Address |
Kasturba Medical College,Madhav Nagar,Manipal,Karnataka,India,Pin Code-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 Rajika Khanna |
Kasturba Medical College Manipal |
Department of General Medicine,Madhav Nagar,Manipal,Karnataka,India,Pin Code-576104
Udupi
KARNATAKA |
7022889430
rajikakhanna2309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba hospital institutional Ethics Committe - Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed to have sepsis by sepsis 3 guidelines and seeking treatment for the same at kasturba Medical College under General Medicine Department. |
|
| ExclusionCriteria |
| Details |
Pre-existing Valvular Heart Disease/ Pre-existing Congenital Heart Disease/ Pregnancy/ Atrial Fibrillation/Cardiac arrest within 48 hours of presentation/ Ascites/ Pneumothorax |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence of various cardiac manifestations in patients diagnosed as sepsis in order to understand specific treatment provided depending on cardiac outcomes. |
24 hours,28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To draw comparison between various cardiac phenotypes through deranged
clinical parameters,prognosis and mortality rates. |
24 hours 28 day |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
10/07/2024 |
| 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="9"
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
|
The proposed study involves obtaining ethical clearance and informed consent before conducting a prospective, longitudinal investigation into sepsis among ICU patients. It will recruit patients diagnosed with sepsis using the SOFA score, focusing on those admitted under general medicine. Data collection will include medical history, laboratory results, and clinical assessments. Echocardiography within 24 hours of admission will evaluate cardiac function, with particular attention to indicators of distributive or hypodynamic shock. RV dysfunction will be assessed using TAPSE, and the IVC diameter will be measured. Patient safety and confidentiality will be paramount throughout the study. Follow-up will continue for 28 days post-admission to monitor patient outcomes. |