Pharmacokinetics of Invanz® (Ertapenem) in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Ertapenem Transmembrane Clearance by Continuous Hemodialysis.
研究概览
简要总结
Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients. Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. This study will determine how much ertapenem is removed by continuous hemodialysis.
详细描述
Subjects receiving CVVHD will receive a one gram dose of ertapenem. Serial blood samples over 24 hours will be taken to assess the ertapenem blood concentrations over time. Spent dialysate and urine samples (if any) will also be measured for ertapenem content to determine how much drug is removed by CVVHD and kidneys. A pharmacokinetic evaluation will be made to determine what is the most appropriate dose for this drug in patients receiving CVVHD to achieve pharmacokinetic and pharmacodynamic goals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- •Hospitalized in ICU
- •Receiving Continuous hemodialysis
- •Prescribed ertapenem
- •Informed consent granted
排除标准
- •< 18 years of age
- •Allergy to ertapenem or other carbapenem antibiotic
- •Severe, life-threatening reaction to penicillin or cephalosporins
- •Patients experiencing or with history of CNS disorders (eg: seizure, stroke)
- •Patients experiencing CNS infection
- •Inability to complete 24 hours of CVVHD
- •Concurrent use of other extracorporeal therapies such as extracorporeal membrane oxygenation, plasmapheresis or intermittent hemodialysis
- •Inability to obtain informed consent
- •Pregnant and/or breastfeeding women
研究组 & 干预措施
ertapenem
subjects will receive ertapenem while receiving CVVHD
干预措施: ertapenem (Drug)
结局指标
主要结局
Ertapenem Transmembrane Clearance by Continuous Hemodialysis.
时间窗: 24 hours after receiving first 1 gram dose
次要结局
未报告次要终点
研究者
Bruce A. Mueller
Professor of Pharmacy
University of Michigan