Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Number of participants with amikacin PK/PD target attainment
研究概览
简要总结
The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied
排除标准
- •< 18 years
- •pregnancy
- •amikacin treatment in the previous 2 weeks
- •known allergy to aminoglycosides
- •Do Not Reanimate Code ≥ 2
- •Hospitalized patients with a prolonged deep venous or arterial catheder
- •Continuous renal replacement, intermittent hemodialysis and death within the time of start of amikacin replacement and 1 hour later
研究组 & 干预措施
amikacin standard dose
amikacin in a single standard dose
干预措施: Amikacin (Drug)
amikacin dose for critical care patients
amikacin in a single dose for critical care patients
干预措施: Amikacin (Drug)
结局指标
主要结局
Number of participants with amikacin PK/PD target attainment
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
The primary outcome of this study was evaluation of PK/PD target attainment defined as amikacin peak concentration/Minimal Inhibitory Concentration \> 8 in the 15 vs.25 mg/kg amikacin group in function of 1) actual MIC of isolated pathogens 2) breakpoints of European Committe on Antimicrobial susceptibility testing (EUCAST) of Enterobacteriaceae and Pseudomonas aeruginosa
次要结局
未报告次要终点
研究者
mevr Sabrina De Winter
PharmD - KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium
Universitaire Ziekenhuizen KU Leuven