| CTRI Number |
CTRI/2025/11/097184 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two simple blood measures to predict recovery in children with severe infection |
|
Scientific Title of Study
|
Comparison of blood lactate-to-bicarbonate ratio versus blood lactate alone for predicting outcomes in children with 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 |
Dr Jyoti Antil |
| Designation |
Post graduate student |
| Affiliation |
University college of medical sciences, GTB hospital |
| Address |
C 35-Z1, Third floor, Block -C , GTB enclave, GTB hospital
Paediatrics department Room number 10
Paediatrics department, OPD Room number 10
North East
DELHI
110095
India |
| Phone |
9306437255 |
| Fax |
|
| Email |
4.92.jyotiantil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Narang |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences |
| Address |
Guru Tegh Bahadur Hospital,UCMS Delhi
Paediatrics Department,OPD Room number 10
Paediatrics Department,OPD Room number 10
New Delhi
DELHI
110095
India |
| Phone |
9625900829 |
| Fax |
|
| Email |
manish_2710@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Antil |
| Designation |
Post graduate student |
| Affiliation |
University college of medical sciences, GTB hospital |
| Address |
C 35-Z1, Third floor, Block -C , GTB enclave,GTB Hospital
Paediatrics Department,OPD Room number 10
Paediatrics Department,OPD Room number 10
North East
DELHI
110095
India |
| Phone |
9306437255 |
| Fax |
|
| Email |
4.92.jyotiantil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES GTB HOSPITAL INSTITUTE |
| Address |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES ,GURU TEG BAHADUR HOSPITAL, 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 Jyoti Antil |
University college of medical sciences ,GTB Hospital |
Department of Paediatrics room no 10 opd Ucms & GTB Hospital
New Delhi
DELHI |
9306437255
4.92.jyotiantil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE-HUMAN RESEARCH (IEC-HR) UNIVERSITY COLLEGE OF MEDICAL SCIENCES,UNIVERSITY OF DELHI,DELHI-110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with septic shock of age 1 to 12 years |
|
| ExclusionCriteria |
| Details |
Children with known metabolic disorders or inborn errors of metabolism.
Children with chronic liver or kidney disease.
Children on immunosuppressive therapy or known malignancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare in-hospital mortality (defined as death during the hospital admission for septic shock) of children with septic shock using blood lactate-to-bicarbonate ratio versus blood lactate alone as predictors. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate length of hospital stay (in days) ,requirement for mechanical ventilation and duration of mechanical ventilation to blood lactate-to-bicarbonate ratio and blood lactate alone. |
At time of discharge or death |
| To correlate p-SOFA score at baseline to blood lactate-to-bicarbonate ratio and blood lactate alone. |
Within 6 hours of admission |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
21/11/2025 |
| 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="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 observational study at GTB Hospital (Aug 2025–Nov 2026) evaluates whether the blood lactate-to-bicarbonate ratio is a better predictor of clinical outcomes than blood lactate alone in children aged 1–12 years with septic shock. It compares in-hospital mortality, length of stay, ventilatory support needs, and organ dysfunction (p-SOFA scores) across 130 patients. Arterial blood gas analysis will be used to assess biomarkers and guide outcome predictions.
|