Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
研究概览
简要总结
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
详细描述
Antibiotic concentrations are measured whilst patients receive SLED for renal replacement therapy. The plasma specimens will be quantified using high Performance liquid chromatography (HPLC).
Primary endpoint:
- Plasma levels of antiinfectives during SLED
Secondary endpoints:
- mortality
- length of stay at the intensive care unit (ICU) and hospital
- clinical cure of infections
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18 or older
- •patients receiving SLED and either meropenem or ceftazidim
排除标准
- •missing informed consent
结局指标
主要结局
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
时间窗: days receiving SLED, up to 5 days
Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections. Therefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains.
次要结局
- Length of Stay (LOS)(minimum duration of hospital stay, maximum 1 year)
- Mortality(minimum duration of hospital stay, maximum 1 year)
- Number of Patients With Clinical Cure of Infections(minimum duration of hospital stay, maximum 1 year)
研究者
PD Dr. rer. medic. Claudia Langebrake
Head Clinical Research Hospital Pharmacy
Universitätsklinikum Hamburg-Eppendorf