Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The % of time that free concentrations of antimicrobials are above minimal inhibitory concentrations (MIC) or antimicrobial European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints
研究概览
简要总结
In this prospective observational study, the investigators want to document pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used antimicrobials in an adult non critically ill surgery population (abdominal surgery, traumatology and septic orthopedic surgery). Furthermore, the investigators want to identify risk factors for not attaining predefined PK/PD targets.
The antibiotics of interest are amoxicillin(-clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem and clindamycin.
详细描述
In this research proposal, the primary objective is to describe PK parameters (area under the curve (AUC), clearance (Cl), distribution volume (Vd) and half life (T1/2)) for the antibiotics of interest (amoxicillin(-(clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem and clindamycin) for this adult non critically ill surgery population.
Besides, the investigators want to document pharmacokinetic/pharmacodynamic (PK/PD) target attainment of frequently used ABs in this population and to identify risk factors, for example augmented renal clearance (ARC), for not attaining predefined PK/PD targets.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Every adult non-critically ill surgery patient admitted at the abdominal, trauma or septic orthopaedic surgery wards from the University Hospitals Leuven treated with multiple doses of one of the antimicrobials of interest (i.e. intravenous (IV) amoxicillin(-clavulanic acid), flucloxacillin, piperacillin-tazobactam, meropenem, oral or IV clindamycin) is eligible for inclusion.
排除标准
- •age ≤ 18 years
- •treatment restrictions corresponding to a Do Not Reanimate code
- •pregnancy
- •lactation
- •renal replacement therapy
- •planned discharge or surgery in the coming antimicrobial dosing interval making sampling impossible
结局指标
主要结局
The % of time that free concentrations of antimicrobials are above minimal inhibitory concentrations (MIC) or antimicrobial European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints
时间窗: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Per antimicrobial of interest, we will determine the % of time that free concentrations are above minimal inhibitory concentrations (MIC) or antimicrobial EUCAST breakpoints
次要结局
- Half life (T1/2)(During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.)
- Clearance (Cl)(During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.)
- Volume of distribution (Vd)(During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.)
- Risk factors for target non attainment(During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.)
- Area under the plasma concentration versus time curve (AUC)(During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.)
研究者
peter declercq
Principal investigator
Universitaire Ziekenhuizen KU Leuven