| CTRI Number |
CTRI/2025/10/095933 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two medications for septic shock in children- Epinephrine vs norepinephrine |
|
Scientific Title of Study
|
Epinephrine vs Norepinephrine in Fluid Refractory Pediatric Septic Shock- Open labelled randomized trial |
| 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 Yukti Rani |
| Designation |
Post graduate student, department of pediatrics, University college of medical sciences, Delhi |
| Affiliation |
University College of medical sciences and GTB hospital |
| Address |
Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden, Delhi-110095
North East
DELHI
110095
India |
| Phone |
8130780542 |
| Fax |
|
| Email |
yukti.singh47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Bhaskar |
| Designation |
Associate professor, Department of pediatrics, UCMS and GTB hospital, Delhi |
| Affiliation |
University College of medical sciences and GTB hospital |
| Address |
Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden, Delhi-110095
North East
DELHI
110095
India |
| Phone |
9899179508 |
| Fax |
|
| Email |
vikrambhaskar8884@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yukti Rani |
| Designation |
Post graduate student, department of pediatrics, University college of medical sciences, Delhi |
| Affiliation |
University College of medical sciences and GTB hospital |
| Address |
Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden, Delhi-110095
North East
DELHI
110095
India |
| Phone |
8130780542 |
| Fax |
|
| Email |
yukti.singh47@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCMS and GTB hospital, Dilshad Garden, Delhi 110093 |
|
|
Primary Sponsor
|
| Name |
University college of medical sciences and GTB hospital |
| Address |
University college of medical sciences and GTB hospital, Dilshad garden, Delhi- 110093 |
| 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 Yukti Rani |
GTB hospital |
Pediatric Intensive care unit, 2nd floor, MCH building, GTB hospital, Dilshad garden, Delhi
North East
DELHI |
8130780542
yukti.singh47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH |
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 |
Epinephrine in fluid refractory pediatric septic shock. |
Subjects will be randomized to receive epinephrine starting at dose of 0.1 microgram/kg/min to be administered via iv route. Baseline parameters will be obtained including vital sign, arterial blood gas, blood cultures. After initiation of infusion of the study drug, starting with , subjects will be assessed at 20, 40 and 60 minutes interval for reversal of shock. in case of no improvement at serial 20 minute evaluation, serial dose of the drug will be increased upto maximum of 0.4 micrograms/kg/min. Monitoring of patient to be done till their duration of stay in PICU |
| Comparator Agent |
Norepinephrine in fluid refractory pediatric septic shock. |
Subjects will be randomized to receive norepinephrine. starting at dose of 0.1 microgram/kg/min to be administered via iv route. Baseline parameters will be obtained including vital sign, arterial blood gas, blood cultures. After initiation of infusion of the study drug, starting with , subjects will be assessed at 20, 40 and 60 minutes interval for reversal of shock. in case of no improvement at serial 20 minute evaluation, serial dose of the drug will be increased upto maximum of 0.4 micrograms/kg/min. Serial monitoring done till the duration of stay of patient in picu. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1year- 12 years with a diagnosis of septic shock not responding to fluid therapy (up to 60ml/kg) will be included. |
|
| ExclusionCriteria |
| Details |
Children with known cardiac disease, immunodeficiency state, lethal congenital anomaly, and those who have received vasoactive drug prior to admission will be excluded. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving reversal of shock at 60 minutes. |
Proportion of patients achieving reversal of shock at 60 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the two groups on the basis of- Mortality rate - Mean Duration of PICU stay - Requirement of other vasoactive agents. |
follow up till the stay of patient in Pediatric ICU. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/10/2025 |
| 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 study has been designed to compare the efficacy of epinephrine vs norepinephrine as first line agent in children with fluid refractory septic shock. Primary objective is to assess and compare hemodynamic status of patients receiving epinephrine (control) vs norepinephrine (intervention group) in fluid refractory septic shock in terms of time taken to achieve reversal of shock at 1st hour. Sepsis is a leading cause of morbidity, mortality, and healthcare utilization for children worldwide. It is a life-threatening organ dysfunction resulting from a dysregulated host response to infection, leading to systemic inflammation and potential multiorgan failure.In Pediatric populations, sepsis and septic shock pose significant health challenges. The majority of children who die of sepsis suffer from refractory shock and/or multiple organ dysfunction syndrome, with many deaths occurring within the initial 48 to 72 hours of treatment. Hence there is a critical need for timely recognition and intervention to improve outcomes in affected children. Both epinephrine and norepinephrine are recommended as first-line vasoactive agents in pediatric septic shock. There is lack of consensus and limited direct comparative studies in children and hence there is need for robust evidence to guide optimal first-line therapy.
Hence this study is designed to compare the effect of the two drugs in reversal of shock within the first hour of initiation of the drugs. |