Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving CVVHD and/or ECMO
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance
研究概览
简要总结
Critically ill patients with flu may receive a drug called oseltamivir. They may also receive medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO) and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD and ECMO may remove some oseltamivir from the bloodstream. The purpose of this study is to determine how much oseltamivir gets removed by CVVHD or ECMO in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •receiving Continuous Venovenous Hemodialysis (CVVHD) or Extracorporeal Membrane Oxygenation (ECMO)
- •require oseltamivir treatment
- •informed consent granted
排除标准
- •unable to complete 12 hours of CVVHD or ECMO
- •<6 kg body weight
- •allergy to oseltamivir
研究组 & 干预措施
ECMO alone
Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy (patients were already receiving oseltamivir and ECMO due to an illness)- Procedure/Surgery: pharmacokinetic blood sampling
干预措施: pharmacokinetic blood sampling (Procedure)
CVVHD Alone
Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir (Patients were already receiving oseltamivir and CVVHD as a result of an illness).
Procedure/Surgery: pharmacokinetic blood and dialysate sampling
干预措施: pharmacokinetic blood and dialysate sampling (Procedure)
CVVHD + ECMO
Patient receiving oseltamivir and ECMO and CVVHD (patients were already receiving oseltamivir, ECMO, and CVVHD as part of an illness).
Procedure/Surgery: pharmacokinetic blood and dialysate sampling
干预措施: pharmacokinetic blood and dialysate sampling (Procedure)
结局指标
主要结局
Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance
时间窗: 12 hours
Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).
Oseltamivir Carboxylate Removal by ECMO
时间窗: 12 hours
Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.
次要结局
未报告次要终点
研究者
Bruce A. Mueller
Professor
University of Michigan