| CTRI Number |
CTRI/2022/11/047652 [Registered on: 25/11/2022] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The use of cardiac ECHO for prediction of an outcome in septic shock patients |
|
Scientific Title of Study
|
Myocardial performance Index for
prediction of an outcome in septic shock patients: A prospective observational cohort
study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bankar Prashant Lalaso |
| Designation |
(DM) Academic Senior Resident |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
Department of Anaesthesiology, pain medicine and critical care,
AIIMS hospital, New Delhi
Department of Anaesthesiology, pain medicine and critical care,
AIIMS hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910659461 |
| Fax |
|
| Email |
pradhantbankar15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bankar Prashant Lalaso |
| Designation |
(DM) Academic Senior Resident |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
Department of Anaesthesiology, pain medicine and critical care,
AIIMS hospital, New Delhi
Department of Anaesthesiology, pain medicine and critical care,
AIIMS hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910659461 |
| Fax |
|
| Email |
pradhantbankar15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganga Prasad |
| Designation |
Professor |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
Department of Anaesthesiology, pain medicine and critical care,
AIIMS hospital, New Delhi
Department of Anaesthesiology, pain medicine and critical care,
AIIMS hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013232965 |
| Fax |
|
| Email |
drgpd@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,pian medicine and critical care,
AIIMS, New delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Department of Anaesthesiology, pain medicine and critical care,
AIIMS hospital, New Delhi |
| 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 Bankar Prashant Lalaso |
AIIMS HOSPITAL, NEW DELHI |
5th floor, Anaesthesia department , Main Building,
South
DELHI |
9910659461
pradhantbankar15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATION RESEARCH,AIIMS , NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. All non-pregnant patients 18 -75 years of age who met the Surviving Sepsis Campaign-2021 definition of septic shock. |
|
| ExclusionCriteria |
| Details |
1. Refusal of consent
2. Patient with septic shock who has received treatment at another hospital and later referred to AIIMS.
3. Atrial or ventricular arrhythmias, including bundle branch blocks and frequent premature ventricular contractions.
4. Known or new onset valvular disease.
5. Suspected infective endocarditis.
6. Acute coronary syndrome
7. Cor pulmonale or COPD.
8. Acute renal failure at presentation
9. Pregnant patients.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict the 28 day mortality in septic shock patients by using the myocardial performance index. |
To measure the myocardial performance index at enrolment (0hours) ,24 hours .
Assessing the patient status at 28 day after enrolment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether there is correlation between MPI and Trop-I,NT- proBNP in septic shock patients. |
To measure the Trop-I,NT- proBNP at enrolment and 24 hours later.
Assessing the patient status at 28 day after enrolment . |
To predict the length of hospital stay,
-Length of ICU stay,
-Duration of mechanical ventilation.
|
Till the patient is discharged/ death. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2022 |
| Date of Study Completion (India) |
30/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Sepsis induced cardiac dysfunction is well known complication in patients with septic shock, with Incidence rate around 40-50%and associated with high mortality. Multiple invasive parameters(SVR,CO/CI, by TPTD, flow trac,etc)serum Biomarkers- procalcitonin, NT proBNP, cardiac troponins (I & T), CRP etc and non invasive parameters( ECHO for systolic and diastolic dysfunction)used to predict severity and outcome. All parameters have some limitations; none of these are accurate independent predictors. A new ECHO parameter, myocardial performance index which indicates both systolic and diastolic function of the heart and is independent of heart rate, preload and afterload conditions of the heart, so it can be more correlated with sepsis induced cardiomyopathy changes. Previous studies have compared serum biomarkers with either systolic/diastolic dysfunction or ejection fraction in septic shock patients. MPI as a non-invasive and quick bedside measure can equally or more superiorly be used to predict the 28 day mortality. And we assume that MPI can be correlated well with Serum Trop-I and NTproBNP. |