Development and Use of a Population Pharmacokinetic Model of Amikacin and Vancomycin for the Optimization of Dosing Regimens in Critically Ill Patients on Different Modalities of Extracorporeal Hemoadsorption
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Development of population pharmacokinetic model
研究概览
简要总结
The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of SIRS, sepsis and/or septic shock,
- •older than 18 years, who are being treated with amikacin and/or vancomycin,
- •length of use of adsorbent at least 12 hours.
排除标准
- •contraindication for hemodiafiltration with adsorbents,
- •patients under the age of 18,
- •terminal cancer patients.
结局指标
主要结局
Development of population pharmacokinetic model
时间窗: One year
Measurement of amikacin and vancomycine serum concentrations in several time points in order to gain pharmacokinetic profiles of previously mentioned drugs and to develop population pharmacokinetic model of amikacin and vancomycin by nonlinear modeling of combined effects in critically ill patients on veno-venous hemodiafiltration with two types of adsorbents.
次要结局
未报告次要终点
研究者
Nikolina Spiric
MPharm
University Clinical Centre of Republic of Srpska