NCT00556361已完成2 期
Use of Ketamine Prior to Cardiopulmonary Bypass in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare expression of serum markers of CNS injury
研究概览
简要总结
To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than one year of age
- •undergoing cardiac surgery for repair of ventricular septal defect
- •requiring cardiopulmonary bypass
- •not requiring retrogrades cerebral perfusion
排除标准
- •Downs Syndrome
研究组 & 干预措施
1
Placebo Comparator
干预措施: saline (Drug)
2
Experimental
干预措施: ketamine (Drug)
结局指标
主要结局
To compare expression of serum markers of CNS injury
时间窗: within 48 hours
to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.
时间窗: within 48 hours
次要结局
- to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls(one month)
研究者
研究点 (1)
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