Population Pharmacokinetics of Teicoplanin, Levofloxacin, Piperacillin/Tazobactam, Meropenem, Vancomycin, Remifentanil, Cefepime, Cefpirome, Sufentanil, Midazolam, Clopidogrel, Ticagrelor, Prasugrel During Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Serum or plasma concentration
研究概览
简要总结
Extracorporeal membrane oxygenation (ECMO) is the device which increases the supply of oxygen to the body tissues in vitro and to assist in heart and lung function. Venoarterial (VA) ECMO is used in patients with cardiogenic shock, cardiac arrest, ventricular arrhythmia and is able to secure a time to self-recovery by reducing the excessive stimulation applied to the heart. However, in ECMO patients, pharmacokinetics of drugs are changing such as increased volume of distribution (Vd) or decreased clearance (CL). For this reason, it is hard to provide the best treatment in ECMO patients. The study is to evaluate whether the PK of drugs is influenced by VA ECMO and to recommend the optimal dosing strategies for proposed drugs in adult 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
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who are ≥ 19 years old and receiving VA ECMO in Severance Hospital, Yonsei University Health System.
- •patient who are receiving one of these drugs: teicoplanin or levofloxacin or piperacillin/tazobactam or meropenem or vancomycin or remifentanil or cefepime or cefpirome or sufentanil or midazolam or clopidogrel or ticagrelor or prasugrel
- •patients who are agreed to participate in this study
排除标准
- •patients who are pregnant
- •patients who are receiving drugs that could affect study drug's concentration due to drug-drug interaction.
结局指标
主要结局
Serum or plasma concentration
时间窗: Between day0 to day3 after removing ECMO
Serum or plasma concentration of teicoplanin or levofloxacin or piperacillin/tazobactam or meropenem or vancomycin or remifentanil or cefepime or cefpirome or sufentanil or midazolam or clopidogrel or ticagrelor or prasugrel
Pharmacokinetic parameter: Cmax
时间窗: Between day0 to day3 after removing ECMO
Pharmacokinetic parameter: Tmax
时间窗: Between day0 to day3 after removing ECMO
volume of distribution
时间窗: Between day0 to day3 after removing ECMO
elimination half life
时间窗: Between day0 to day3 after removing ECMO
Clearance
时间窗: Between day0 to day3 after removing ECMO
absorption rate constant
时间窗: Between day0 to day3 after removing ECMO
absorption rate constant (if the drug is orally administered),
area under the curve (AUC)
时间窗: Between day0 to day3 after removing ECMO
area under the curve (AUC) (if possible)
次要结局
未报告次要终点
