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临床试验/NCT02581280
NCT02581280已完成不适用

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)

Yonsei University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2014年12月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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