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临床试验/CTRI/2025/10/095933
CTRI/2025/10/095933尚未招募3 期

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

University college of medical sciences and GTB hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Proportion of patients achieving reversal of shock at 60 minutes.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

Proportion of patients achieving reversal of shock at 60 minutes.

时间窗: Proportion of patients achieving reversal of shock at 60 minutes.

次要结局

  • 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.)

研究者

发起方
University college of medical sciences and GTB hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Yukti Rani

University College of medical sciences and GTB hospital

研究点 (1)

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