Evaluation of Sulfobutylether-ß-cyclodextrin Sodium (SBECD) Accumulation and Voriconazole Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determine SBECD plasma and effluent concentrations
研究概览
简要总结
This study's primary objective is to determine if continuous renal replacement therapy (CRRT) can adequately remove the sulfobutylether-ß-cyclodextrin sodium (SBECD) vehicle from the blood so that intravenous voriconazole can be utilized in critically ill patients with renal dysfunction requiring dialysis. Secondarily, the pharmacokinetics of intravenous voriconazole and its metabolite (UK121-265) and adverse effects of SBECD accumulation will also be evaluated. The study hypothesis is that CRRT is effective at removing SBECD and allows patients to receive intravenous voriconazole without the concern of SBECD accumulation.
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 are receiving continuous renal replacement therapy and are prescribed voriconazole therapy for the treatment or prophylaxis of a fungal infection.
排除标准
- •Patients expected to be on CRRT for < 5 days,
- •Patients with Child-Pugh C cirrhosis, and
- •Patients who are pregnant.
研究组 & 干预措施
Voriconazole
Pharmacokinetic Monitoring
干预措施: Voriconazole (Drug)
结局指标
主要结局
Determine SBECD plasma and effluent concentrations
时间窗: Days 1-7
Evaluate SBECD pharmacokinetics (Cmax, Cmin, AUC, half-life, CL, seiving coefficient). Predict time to SBECD accumulation in study patients
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Days 1-30)
- Determine Voriconazole and UK121-265 plasma and effluent concentrations(Days 1-7)