Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Although, hydrocortisone has shown promise in managing refractory shock, its role in early septic shock management remains unclear. This study aims to provide robust evidence on the clinical and hemodynamic outcomes of early hydrocortisone use in pediatric septic shock, contributing to standardized treatment protocols and improved survival rates.
详细描述
Despite global advancements in pediatric critical care, mortality and morbidity in septic shock remain unacceptably high. Although data suggest a reduction in mortality with steroid therapy in refractory shock, specific data for hydrocortisone in pediatrics are limited. The findings of this study would not only be a valuable addition to the existing stats but might also help develop a protocol for the use of hydrocortisone therapy in children with septic shock, seeking an earlier recovery from organ failure, earlier reversal of shock, and lower mortality in children with sepsis and septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of any gender
- •Aged 2 month to 12 years
- •Diagnosed with septic shock
- •Admitted to the pediatric intensive care unit
排除标准
- •Known adrenal insufficiency or congenital adrenal hyperplasia
- •History of corticosteroid use within the past 7 days
- •Terminal illness or "do-not-resuscitate (DNR)" status
- •Severe immunocompromise (e.g., advanced malignancy, HIV stage IV)
- •Known allergy to hydrocortisone
研究组 & 干预措施
Hydrocortisone Group
Children will receive early intravenous hydrocortisone at 2 mg/kg/day divided every 6 hours, continued for 7 days or until resolution of shock.
干预措施: Standard care (Drug)
Hydrocortisone Group
Children will receive early intravenous hydrocortisone at 2 mg/kg/day divided every 6 hours, continued for 7 days or until resolution of shock.
干预措施: Intravenous Hydrocortisone (Drug)
Standard Care Group
The children will be managed by following standard institutional treatment protocol.
干预措施: Standard care (Drug)
结局指标
主要结局
Mortality
时间窗: 28 days
The mortality will be labeled 'yes' if a patient dies within 28 days of admission.
次要结局
- Length of pediatric intensive care unit stay(28 days)
- Duration of vasopressor(28 days)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research