Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Determination of drug specific sieving coefficient (SC)
研究概览
简要总结
The purpose of the study is to measure levels of any of the following AEDs (levetiracetam, phenobarbital, phenytoin, ketamine, valproic acid, lacosamide) in blood and effluent on critically ill patients receiving CRRT in order to characterize drug pharmacokinetics and optimize dosing strategies in patients on CRRT.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected to be on CRRT and receive any of the following for more than 24 hrs
- •Expected to survive for more than 24 hrs
- •Achievement of steady state drug concentrations prior to study enrollment
排除标准
- •Pregnancy
- •Age < 18
研究组 & 干预措施
No study intervention
No study intervention
干预措施: Phenobarbital (Drug)
No study intervention
No study intervention
干预措施: Ketamine (Drug)
No study intervention
No study intervention
干预措施: Levetiracetam (Drug)
No study intervention
No study intervention
干预措施: Lacosamide (Drug)
No study intervention
No study intervention
干预措施: Phenytoin (Drug)
No study intervention
No study intervention
干预措施: Valproic Acid (Drug)
结局指标
主要结局
Determination of drug specific sieving coefficient (SC)
时间窗: Single Dosing Interval - 12 hours
SC is a measure of a filter efficiency in clearing drugs and solute. SC will be calculated using pre-filter and effluent concentrations
Influence of renal replacement therapy on drug exposure (AUC of plasma concentration levels)
时间窗: Single Dosing Interval - 12 hours
Simultaneous samples will be taken from pre-filter, post-filter, and effluent sampling ports before dose administration, after the completion of the infusion or 1 hours post oral dose, and 6 additional time points post-infusion or post oral administration.
Influence of renal replacement therapy on drug clearance
时间窗: Single Dosing Interval - 12 hours
Simultaneous samples will be taken from pre-filter, post-filter, and effluent sampling ports before dose administration, after the completion of the infusion or 1 hours post oral dose, and 6 additional time points post-infusion or post oral administration.
次要结局
未报告次要终点
研究者
Neeraj Badjatia
Professor of Neurology
University of Maryland, Baltimore