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.
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.
Study Type
OBSERVATIONAL
Enrollment
120
During one dosing interval at steady state of the involved antimicrobials (ABs), AB plasma concentrations will be determined. Besides, the measured creatinine clearance based on an 8-hour urinary collection (CrCl8h) will be used as the primary method for determining kidney function. Based on these values, CrCl8h will be calculated according to the standard formula and normalized to a body surface area (BSA) of 1.73m² .
University Hospitals Leuven
Leuven, Belgium
RECRUITINGThe % of time that free concentrations of antimicrobials are above minimal inhibitory concentrations (MIC) or antimicrobial European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints
Per antimicrobial of interest, we will determine the % of time that free concentrations are above minimal inhibitory concentrations (MIC) or antimicrobial EUCAST breakpoints
Time frame: 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)
Per antimicrobial of interest, we will determine the pharmacokinetic parameter the area under the plasma concentration versus time curve (AUC).
Time frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Clearance (Cl)
Per antimicrobial of interest, we will determine the pharmacokinetic parameter clearance (Cl).
Time frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Volume of distribution (Vd)
Per antimicrobial of interest, we will determine the pharmacokinetic parameter the volume of distribution (Vd).
Time frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Half life (T1/2)
Per antimicrobial of interest, we will determine the pharmacokinetic parameter the half life (T1/2).
Time frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.
Risk factors for target non attainment
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Multivariate analysis will be performed with target attainment as outcome. This will allow to identify risk factors for target non attainment.
Time frame: During 1 dosing interval at steady state. This is at earliest 72h after initialization of the antimicrobial.