| CTRI Number |
CTRI/2025/05/087162 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Longitudional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare various Septic Shock indices in infants with sepsis post congenital heart surgery. |
|
Scientific Title of Study
|
Comparision of Septic Shock indices in Post - Congenital Cardiac Surgery sepsis in Infants- A single centre Prospective Longitudional 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 Venuthurupalli SP Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803, 8th Floor, A block, UN Mehta Institute of Cardiology and Research Centre, Ahmadabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venuthurupalli SP Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803, 8th Floor, A block, UN Mehta Institute of Cardiology and Research Centre, Ahmadabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venuthurupalli SP Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803, 8th Floor, A block, UN Mehta Institute of Cardiology and Research Centre, Ahmadabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
|
Source of Monetary or Material Support
|
| UN Mehta Institute of Cardiology and Research Centre, Ahmadabad, Gujarat, India, 380016 |
|
|
Primary Sponsor
|
| Name |
Dr Venuthurupalli SP Rajesh |
| Address |
Room no 803, 8th Floor, A block, UN Mehta Institute of Cardiology and Research Centre, Ahmadabad, Gujarat, India, 380016 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhawana Sharma |
Room no 803, 8th Floor, A block, UN Mehta Institute of Cardiology and Research Centre, Ahmedabad, Gujarat, India, 380016 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venuthurupalli SP Rajesh |
UN Mehta Institute of Cardiology and Research Centre |
Room no 803, 8th Floor, A block, UN Mehta Institute of Cardiology and Research Centre,380016
Ahmadabad
GUJARAT |
7799026386
rajeshvsp.88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee UN Mehta Institute of Cardiology and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
29.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
patients developing sepsis post congenital cardiac surgery and getting admitted in the recovery room. |
|
| ExclusionCriteria |
| Details |
Patients less than 29 days, patients more than 1 year, patients with preoperative sepsis, patients not developing sepsis post operatively. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the association between Shock Index, Modified Shock Index and Diastolic Shock Index and outcome in Sepsis in infant Cardiac Surgery. |
At baseline (0 hour), 1 hour, 2 hour and 6 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To diagnose sepsis using Tollner sepsis scoring system and EMA sepsis scoring system by measuring heart rate and blood pressure. |
At baseline (0 hour), 1 hour, 2 hour and 6 hour. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/06/2025 |
| 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="0"
Months="8"
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
|
New
surgical methods, increased perioperative care has caused a boost of congenital
cardiac surgeries in third-world countries, leading to a greater number of infant congenital cardiac surgeries in underdeveloped countries because of
the increase in infant cardiac surgical procedures with better results, even
though significant postoperative illnesses and mortality remain mainly because
of sepsis. Initial
resuscitation of shock is commonly guided by the normalization of hemodynamic
and laboratory variables such as HR, BP, central venous pressure, and lactic
acid. SI
may be a good and non
invasive
measure of the degree of hemodynamic stability and may be used as an indicator
of tissue perfusion. It
has been shown to
correlate with other indices of end‑organ perfusion such as central vena cava
oxygen saturation and lactate concentration. We will examine if SI, DSI and MSI can be
employed as a non-invasive tool to identify neonates with a heightened
mortality risk than HR and BP in post-cardiac surgical patients with sepsis.
|