CTRI/2019/12/022391尚未招募不适用
Effect of various feeding regimen on mortality in critically ill pediatric patients of a pediatric critical care unit– A triple arm randomized control trail
No sponsor1 个研究点 分布在 1 个国家目标入组 561 人开始时间: 2019年12月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 561
- 试验地点
- 1
- 主要终点
- 28 day Mortality
研究概览
简要总结
This is a triple arm randomized trial planned in critically ill children going to get admitted in tertiary level Pediatric Intensive Care Unit. This trial wants to study the effect of various feeding protocols in terms of normocaloric normal protien, Hypocaloric high protien, Hypercaloric high protien diet on 28 day mortality
the rationale for this study is that there providing high protien restricted calories during initial period of critical illness prevents autophagy and improves outcome
our study will be based on schofield equation ( recomnended by ASPEN 2018) Energy requirement in critically ill children
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Septic group- All children, 6 month to 12 years old, with sepsis as per sepsis III definition
- •Non-septic group-All children, 6 month to 12 years old, without sepsis and admitted in PICU.
排除标准
- •1.Enteral feed intolerance as defined
- •Major gastrointestinal bleed as defined
- •Protracted ileus 4.Immediate Post-operative abdominal surgery 5.Small bowel ischemia or obstruction 6.Oliguric AKI ( KIDIGO stage 3)
- •Know case of Chronic renal failure
- •Acute liver failure
- •Inborn error of metabolism 10.Diabetic ketoacidosis.
结局指标
主要结局
28 day Mortality
时间窗: 28 days post enrollment
次要结局
- 1. Duration of PICU stay(2.Duration of hospital stay)
研究者
研究点 (1)
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