Pharmacologic Impact on Sedation Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- In children who are mechanically ventilated, to quantitatively define the heritable factors that underlie the variability in 1) midazolam and 2) morphine exposure and response.
研究概览
简要总结
PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.
详细描述
PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This project will use sophisticated modeling and simulation techniques to evaluate the impact of genetics and other variables such as degree of illness, age, weight and organ dysfunction on the pharmacokinetics and pharmacodynamics of morphine and midazolam in children who are mechanically ventilated for respiratory failure, and require sedation. This proposed work will allow the design of a pharmacologic model that can be used to individualize therapy in children requiring mechanical ventilation with the goal of optimizing sedation while minimizing the duration of mechanical ventilation. This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in RESTORE clinical trial
- •Be greater than or equal to 7 kg
- •Receiving morphine and/or midazolam continuous infusions
- •Give Informed Consent/Assent
排除标准
- •Intubated and mechanically ventilated for immediate post-operative care and stabilization
- •Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- •History of single ventricle at any stage of repair
- •Congenital diaphragmatic hernia or paralysis
- •Primary pulmonary hypertension
- •Critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
- •Ventilator dependent (including noninvasive) on Pediatric Intensive Care Unit (PICU) admission (chronic assisted ventilation)
- •Neuromuscular respiratory failure
- •Spinal cord injury above the lumbar region
- •Pain managed by patient controlled analgesia (PCA) or epidural catheter
- •Family/medical team has decided not to provide full support (patient treatment considered futile)
- •Enrolled in any other sedation clinical trial concurrently or within the last 30 days
- •Known allergy to any of the study medications.
结局指标
主要结局
In children who are mechanically ventilated, to quantitatively define the heritable factors that underlie the variability in 1) midazolam and 2) morphine exposure and response.
时间窗: 36-48 months
This is a pharmacokinetic, pharmacogenetic and pharmacodynamic study examining heritable (specific polymorphisms) on drug exposure, metabolite formation and pharmacodynamic response.
次要结局
- In children who are mechanically ventilated, to quantitatively define the non-heritable factors that underlie the variability in 1) midazolam and 2) morphine exposure and response.(36-48 months)