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Clinical Trials/CTRI/2025/10/095933
CTRI/2025/10/095933Not yet recruitingPhase 3

Epinephrine vs Norepinephrine in Fluid Refractory Pediatric Septic Shock- Open labelled randomized trial

University college of medical sciences and GTB hospital1 site in 1 country70 target enrollmentStarted: October 22, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Proportion of patients achieving reversal of shock at 60 minutes.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
1.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children aged 1year- 12 years with a diagnosis of septic shock not responding to fluid therapy (up to 60ml/kg) will be included.

Exclusion Criteria

  • Children with known cardiac disease, immunodeficiency state, lethal congenital anomaly, and those who have received vasoactive drug prior to admission will be excluded.

Outcomes

Primary Outcomes

Proportion of patients achieving reversal of shock at 60 minutes.

Time Frame: Proportion of patients achieving reversal of shock at 60 minutes.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
University college of medical sciences and GTB hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Yukti Rani

University College of medical sciences and GTB hospital

Study Sites (1)

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