| CTRI Number |
CTRI/2025/09/094167 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of steroids alongwith standard care on length of hospital stay in children between age 1-18 years with septic shock |
|
Scientific Title of Study
|
The Effect of Steroids in Paediatric Septic Shock in Addition to Standard Care on Length of Hospital Stay |
| 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 Sudha Chandelia |
| Designation |
Associate Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room number-403,4th floor Academic Block- PGI Building, ABVIMS and Dr RML Hospital
New Delhi
Room number-403,4th floor
Academic Block- PGI Building, ABVIMS and Dr RML Hospital
New Delhi
Central
DELHI
110001
India |
| Phone |
7982425172 |
| Fax |
|
| Email |
sudhach83@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Chandelia |
| Designation |
Associate Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Room number-403,4th floor
Academic Block- PGI Building, ABVIMS and Dr RML Hospital
New Delhi
Room number-403,4th floor
Academic Block- PGI Building, ABVIMS and Dr RML Hospital
New Delhi
Central
DELHI
110001
India |
| Phone |
7982425172 |
| Fax |
|
| Email |
sudhach83@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shriya Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
PICU, Deptt of Paediatrics,ECS 4th floor
ABVIMS and Dr RML Hospital
New Delhi
PICU, Deptt of Paediatrics, ECS 4th floor
ABVIMS and Dr RML Hospital
New Delhi
Central
DELHI
110001
India |
| Phone |
9650646595 |
| Fax |
|
| Email |
singhshriya1099@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
Baba kharak singh marg
Type 3 president estate
New Delhi 110001 |
| 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 Sudha Chandelia |
ABVIMS and Dr RML Hospital |
Paediatric ICU, Department of Paediatrics, ECS 4th floor
Central
DELHI |
7982425172
sudhach83@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitonal Ethics Committee, ABVIMS and RML Hospital, New Delhi-110001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrocortisone |
Interventions will be prepared by an independent department person (Department of Pharmacology) not involved in this RCT. Intervention drug will be Hydrocortisone reconstituted in normal saline with a final concentration of 2mg/ml. Hydrocortisone will be supplied to the treating nursing officer by department of pharmacology with a label of alpha numeral code. Hydrocortisone will be given in the dose 1mg/kg/dose (i.e half volume of the weight of the patient in ml) administered over 15-20 mins every 6 hourly for the next 7 days. Tapering of steroid will be initiated on 8 day as half of the initial drug dose for next 3 days. If during this duration the patient shows signs of shock reversal, then we will stop the treatment with hydrocortisone.
The syringes will be covered with aluminum foil. This will achieve blinding of the intervention. |
| Comparator Agent |
Placebo |
Placebo group will receive normal saline in 50 ml syringe with same appearance, rate of infusion and duration of infusion as that of intervention.
Placebo will be supplied to the treating nursing officer by Department of pharmacology with a label of alpha numeral code. Placebo group will receive normal saline as volume half of the weight of the child administered in 15-20 mins every 6 hourly for the next 7 days. Tapering will be initiated on 8 day as half of the initial drug dose for next 3 days.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Age group- children 1-18 years old
With suspected sepsis
Phoenix sepsis score more than or equal to 2
|
|
| ExclusionCriteria |
| Details |
Immunocompromised patients
Patients with adrenal disease
Patients with Pituitary diseases
Patients with history of long term steroids i.e six months or patients on short term steroids in past 4 weeks.
Tuberculosis patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of steroids in paediatric septic shock in addition to standard care on length of hospital stay
|
Calculated in number of days from date of randomization of the patient in the study to the date of discharge/death of the patient.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to Shock reversal |
Defined as cessation of ionotropes/vasopressors for a minimum duration of 24 hours |
Length of PICU stay
|
Defined from date of randomization to date of shift to ward. |
| To study effect of steroids as compared to placebo on mortality in paediatric septic shock. |
Defined from date of randomization to date of death of patient. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/09/2025 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response (Others) - study level meta analysis
- By what mechanism will data be made available?
Response (Others) - The data will be shared through email - sudhach83@rediffmail.com upon a reasonable request.
- For how long will this data be available start date provided 20-11-2026 and end date provided 30-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After obtaining Institutional Ethics Committee approval and written informed consent from the patients, 25 patients per group will be enrolled for the study. Screening will be done using a predesigned performa for eligibility of the child for inclusion in the study. If the child is eligible for study, consent will be obtained and the child will be randomly assigned to one of the study intervention, study intervention will be started and data will be collected.
Study group will recieve one of the two intervention either Hydrocortisone as interventional steroid alongwith standard care and other group will receive standard care alone. Reconstituted hydrocortisone or placebo will be supplied to the treating nursing officer by central pharmacy with a label of alpha numeral code, which will be available with central pharmacy which will not be in contact with investigator.
|