| CTRI Number |
CTRI/2024/06/069348 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the difference of the partial pressure of CO2 between venous and arterial blood gas in children having septic shock |
|
Scientific Title of Study
|
Assessment of the Peripheral venous to arterial pCO2 gap in Paediatric Septic Shock |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshit Mittal |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
Central
DELHI
110002
India |
| Phone |
9582705762 |
| Fax |
|
| Email |
harshit.mittal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virendra Kumar |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
Central
DELHI
110002
India |
| Phone |
9313985662 |
| Fax |
|
| Email |
drvkumar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshit Mittal |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
Central
DELHI
110002
India |
| Phone |
9582705762 |
| Fax |
|
| Email |
harshit.mittal@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India
Pincode - 110002 |
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital |
| Address |
Department of Paediatrics,
Maulana Azad Medical College and associated Lok Nayak Hospital
Bahadur Shah Zafar Marg
New Delhi
India |
| 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 Harshit Mittal |
Lok Nayak Hospital |
Department of Paediatrics,
Maulana Azad Medical College and associated Lok Nayak Hospital,
New Delhi
Central
DELHI |
9582705762
harshit.mittal@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R578||Other shock, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 1 month to 12 years presenting with septic shock as per the Phoenix Sepsis Criteria given by the International SCCM Paediatric Sepsis Definition Task Force in January 2024 |
|
| ExclusionCriteria |
| Details |
1) Patients who have received fluid boluses or inotropes before presenting in our Paediatrics department
2) Patients who are a known case of cyanotic heart disease and with a known right to left shunt lesion
3) Patients who are a known case of chronic lung disease and chronic kidney disease
4) Patients who are a known case of vasculitis and gangrene
5) Patients who are a known case of cytotoxic hypoxia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in peripheral venous to arterial pCO2 gap |
At 1 hour and 6 hours from 0 hour of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients having high peripheral venous to arterial pCO2 gap |
At 0 hour, 1 hour and 6 hours of treatment |
| Comparison of the proportion of patients having high peripheral venous to arterial pCO2 gap between survivors and non survivors |
At the time of discharge/death |
| Comparison of the proportion of patients having high peripheral venous to arterial pCO2 gap between patients achieving and not achieving shock reversal |
Within 6 hours of treatment |
| Correlation of peripheral venous to arterial pCO2 gap and lactate clearance |
At 1 hour and 6 hours of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2024 |
| 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="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 is an prospective observational study to assess the peripheral venous to arterial pCO2 gap in paediatric septic shock and it will be conducted in the department of Paediatrics of Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi. The primary objective is to determine the change in the peripheral venous to arterial pCO2 gap at 1 hour and 6 hours from the baseline. The secondary objectives are to determine the proportion of patients having high peripheral venous to arterial pCO2 gap at 0 hour, 1 hour and 6 hours; to compare the peripheral venous to arterial pCO2 gap with the outcome and to compare the peripheral venous to arterial pCO2 gap and lactate clearance. Our hypothesis is that the septic shock patients having high peripheral venous to arterial pCO2 gap will have poorer outcomes because of circulatory failure and those patients showing response to treatment in the form of improving pCO2 gap will have better outcomes as compared to those persistently having high peripheral venous to arterial pCO2 gap. |