NCT03293927撤回2 期
Investigating Polypharmacy-related Adverse Events in Critically Ill Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in delirium scores as measured by CAPD score
研究概览
简要总结
The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.
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 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 2-<18 at the time of enrollment
- •Admitted to the Duke PICU or PCICU
- •Planned or anticipated mechanically ventilation for ≥2 days
- •Require sedation to maintain mechanical ventilation
- •No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment
- •Availability and willingness of the parent/legal guardian to provide written informed consent
排除标准
- •Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
- •Previous participation in this study
- •Planned receipt of sedatives other than fentanyl or dexmedetomidine
- •Participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability.
- •Renal failure requiring renal replacement therapy
- •Hepatic failure
- •Support with extracorporeal membrane oxygenation
研究组 & 干预措施
Fentanyl + Dexmedetomidine
Experimental
干预措施: Fentanyl (Drug)
Fentanyl + Dexmedetomidine
Experimental
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine + Fentanyl
Experimental
干预措施: Fentanyl (Drug)
Dexmedetomidine + Fentanyl
Experimental
干预措施: Dexmedetomidine (Drug)
Fentanyl only
Experimental
干预措施: Fentanyl (Drug)
Dexmedetomidine only
Experimental
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Change in delirium scores as measured by CAPD score
时间窗: up to 10 days
次要结局
- Drug level associated with CAPD score(up to 10 days)
研究者
研究点 (1)
Loading locations...
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