CTRI/2024/09/073420尚未招募不适用
A combination therapy of norepinephrine and milrinone as a first-line agent in fluid refractory Pediatric septic shock – a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- The proportion of children attaining shock resolution (achieving all therapeutic endpoints of shock) at 6 hours
研究概览
简要总结
The RCT will evaluate the efficacy of a combination therapy of Norepinephrine and Milrinone as a first-line agent in fluid refractory pediatric septic shock resulting in shock reversal in a greater proportion of children compared to the use of Epinephrine alone in children age one month to 18 years Shock resolution is defined as attainment of all therapeutic endpoints as per surviving sepsis campaign international guidelines.
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 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged one month to 18 years with septic shock, defined as children with suspect or confirmed sepsis and cardiovascular dysfunction, who are fluid refractory, defined as the persistence of features of poor perfusion even after 40 ml/kg of fluid boluses or having clinical features of fluid overload.
排除标准
- •Children with Fulminant myocarditis
- •Children with Congenital heart disease, cardiomyopathy
- •Children already on inotropes at the time of enrolment.
结局指标
主要结局
The proportion of children attaining shock resolution (achieving all therapeutic endpoints of shock) at 6 hours
时间窗: Six hours
次要结局
- 1. Proportion of children achieving therapeutic endpoints at 1st and 24 hours of resuscitation(2. All-cause mortality at discharge or day 28 (whichever is earlier) and duration of PICU stay)
研究者
Man Singh Parihar
AIIMS Rishikesh
研究点 (1)
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