Population Pharmacokinetics of Vancomycin, Meropenem, Milrinone, Dexmedetomidine and Fentanyl in Pediatric Patients During Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter: Volume of distribution
研究概览
简要总结
Extracorporeal membrane oxygenation (ECMO) has been used primarily in newborns since it was first successfully implemented in the 1970s, and has recently increased use in infants and young children. Venoarterial ECMO (VA-ECMO) is a temporary mechanical circulatory support for patients with cardiac failure. Because ECMO is invasive, appropriate use of antimicrobial agent, analgesic and sedatives is important to promote recovery. However, a large variability in drugs pharmacokinetics is expected in pediatric ECMO patients due to the combination of ECMO, drug characteristics and disease factor. This study aimed to evaluate whether the PK of drugs is influenced by VA-ECMO and to recommend the optimal dosing strategies for proposed drugs in pediatric patients receiving VA-ECMO.
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
- 0 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<19 years old
- •receiving VA ECMO in Severance Hospital, Yonsei University Health System.
- •receiving one of these drugs: vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
- •agreed to participate
排除标准
- •receiving drugs that could affect study drug's concentration due to drug-drug interaction
结局指标
主要结局
Pharmacokinetic parameter: Volume of distribution
时间窗: Between day0 to day3 after weaning off ECMO
Volume of distribution of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Pharmacokinetic parameter: Clearance
时间窗: Between day0 to day3 after weaning off ECMO
Clearance of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Serum or plasma concentration
时间窗: Between day0 to day3 after weaning off ECMO
Serum or plasma concentration of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
次要结局
未报告次要终点
