Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Influence of organ replacement therapy on area under curve of doripenem serum concentration
研究概览
简要总结
The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age >18 years
- •Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
- •Organ replacement therapy (MARS, CVVHDF or HD)
排除标准
- •Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
- •An expected survival of less than two days.
- •Known pregnancy
- •Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
- •Doripenem as monotherapy for resistent species or fungal infections.
- •Other reasons opposing the study participation on the discretion of the investigators.
研究组 & 干预措施
Pharmacokinetic profiling in Hemodialysis
Patients with chronic intermittent hemodialysis receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
干预措施: Pharmacokinetic profiling (Other)
Pharmacokinetic profiling in CVVH
Patients receiving continuous venovenous renal replacement therapy in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
干预措施: Pharmacokinetic profiling (Other)
Pharmacokinetic profiling in MARS
Patients receiving liver replacement therapy (MARS) in an ICU setting receiving doripenem therapy are included in this arm. Pharmacokinetic samples are drawn.
干预措施: Pharmacokinetic profiling (Other)
结局指标
主要结局
Influence of organ replacement therapy on area under curve of doripenem serum concentration
时间窗: day 15
Pharmacokinetic samples are drawn from each patient during the trial. Analysis by HPLC will be conducted after the end of the trial.
次要结局
未报告次要终点
研究者
Florian Thalhammer
a.o.Univ.-Prof. Dr.
Medical University of Vienna