NCT00247468撤回不适用
Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- 30-day mortality rate from the time of enrollment
研究概览
简要总结
The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients.
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
- 1 Month 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or
- •Invasive mechanical ventilation
- •Age between 1 mo and 21 yrs
排除标准
- •Type I diabetes mellitus
- •Have an illness that requires insulin daily
- •Recipients of solid organ transplants
- •Participation in an experimental trial that might affect outcome
- •Post-operative patients with planned extubation upon recovery
- •Patients on a dopamine infusion of less than 3 mcg/kg/minute
结局指标
主要结局
30-day mortality rate from the time of enrollment
次要结局
- Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge
- rates of nosocomial bloodstream infections
- time to resolution of organ failure (mechanical ventilator days and days of vasopressor support)
- change in Pediatric Logistic Organ Dysfunction scores
- requirement of dialysis or hemofiltration for patients with acute renal failure
- volume of blood product transfusions per kilogram body weight (vol/kg).
研究者
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