The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma concentration of Levetiracetam
研究概览
简要总结
Levetiracetam (LEV) is one of second-generation antiepileptic drugs that has been used to treat partial and generalized epilepsy. LEV is eliminated from the systemic circulation by renal excretion. Therefore, patients with renal impairment may experience a reduced drug excretion and increased adverse drug reactions. Moreover, patients with end-stage renal disease who need dialysis may experience low serum LEV concentration because of drug loss via dialysis. LEV loss via dialysis can cause low serum level of LEV that insufficient for seizure control. The present study was aimed to evaluate pharmacokinetics of LEV in patients undergoing 4 hour-intermittent hemodialysis (IHD). The results of the study may benefit to determine the appropriate LEV initial dose and supplemental dose for patients undergoing IHD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were at least 18 years old.
- •Patients who were diagnosed with seizure.
- •Patients who were undergoing intermittent hemodialysis and were treated with intravenous Levetiracetam not less than 2 days
排除标准
- •Patients who were pregnant or lactating
- •Patients who were treated with intravenous Levetiracetam more than once a day
- •Patients who were undergoing sustained low efficiency dialysis (SLED)
- •Patients who have intermittent dialysis duration less than 3 hours
结局指标
主要结局
Plasma concentration of Levetiracetam
时间窗: 1 hour after finishing an administration of Levetiracetam post-hemodialysis supplemental dose
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
次要结局
- Plasma concentration of Levetiracetam(1 hour after finishing Levetiracetam administration)
- Number of participants with adverse drug reactions from Levetiracetam(From the first day that participants were included to the study and treated with Levetiracetam until the date of the last point of serum Levetiracetam sampling, assessed up to 3 days)