NCT02866877已完成不适用
Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in systemic levetiracetam clearance over time
研究概览
简要总结
This study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients who have suffered a subarachnoid hemorrhage. The patients will be evaluated for development of augmented renal clearance and the effects and duration of effects this may have on levetiracetam clearance.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with non-traumatic subarachnoid hemorrhage requiring levetiracetam for seizure prophylaxis or treatment
- •Presentation to University of Colorado Hospital within 48 hours of subarachnoid hemorrhage
- •Adults ages 18 to 89 years
- •Anticipated length of stay ≥ 48 hours
- •Informed consent provided by the patient or patient's designated medical proxy
排除标准
- •Pregnancy
- •Patients receiving renal replacement therapy
- •Brain death or imminent brain death expected ≤48 hours
- •Patient with history of nephrectomy or renal transplant
结局指标
主要结局
Change in systemic levetiracetam clearance over time
时间窗: 0-20 days
calculated systemic levetiracetam clearance (based on plasma concentrations) within 48 hours of initial presentation to the neurointensive care unit and every 5 days thereafter up to 20 days
次要结局
- Change in urinary clearance of levetiracetam and creatinine(0-20 days)
研究者
研究点 (1)
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