The adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating pharmacokinetics-pharmacodynamics (PK-PD) target attainment. A population pharmacokinetic study is performed to assist the selection of the optimal individualized dose for patients undergoing intermittent dialysis, taking into consideration as many relevant variables as possible.
Study Type
OBSERVATIONAL
Enrollment
150
During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.
Ghent University Hospital
Ghent, Belgium
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for vancomycin
Measured free and total concentration of the glycopeptide vancomycin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be \>=400 for vancomycin.
Time frame: 9/2016 - 12/2021
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for teicoplanin
Measured free and total concentration of the glycopeptide teicoplanin is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: Area Under the Curve (AUC) from 0-24h in steady-state divided by the Minimum Inhibitory Concentration (MIC) of the suspected pathogen should be \>=750 for teicoplanin.
Time frame: 9/2016 - 12/2021
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for amoxicillin-clavulanic acid
Measured concentration of the beta-lactam amoxicillin-clavulanic acid is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Time frame: 9/2016 - 12/2021
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for piperacillin-tazobactam
Measured concentration of the beta-lactam piperacillin-tazobactam is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Time frame: 9/2016 - 12/2021
Blood concentrations with maximal antimicrobial activity versus current dosing regimens for ceftazidim
Measured concentration of the beta-lactam ceftazidim is compared to predefined pharmacokinetic/pharmacodynamic (PK-PD) targets: minimum percentage of time during which the free drug concentration remains above the Minimum Inhibitory Concentration (MIC) of the micro-organism should be 50%.
Time frame: 9/2016 - 12/2021
Pharmacokinetics of vancomycin in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured vancomycin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured vancomycin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Time frame: 9/2016 - 12/2021
Pharmacokinetics of teicoplanin in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured teicoplanin concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured teicoplanin concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Time frame: 9/2016 - 12/2021
Pharmacokinetics of amoxicillin-clavulanic acid in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured amoxicillin-clavulanic acid concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured amoxicillin-clavulanic acid concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Time frame: 9/2016 - 12/2021
Pharmacokinetics of piperacillin-tazobactam in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured piperacillin-tazobactam concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured piperacillin-tazobactam concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Time frame: 9/2016 - 12/2021
Pharmacokinetics of ceftazidim in patients undergoing intermittent hemodialysis
Population pharmacokinetic modeling is performed based on the measured ceftazidim concentrations, to end up with a calibrated kinetic model. The model is fitted on the measured ceftazidim concentrations in order to determine the model parameters: distribution volume and (inter)dialytic elimination rate constant and clearance.
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of vancomycin
From dialyser inlet and outlet samples, the extraction ratio is calculated for vancomycin and entered in the kinetic analysis
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of teicoplanin
From dialyser inlet and outlet samples, the extraction ratio is calculated for teicoplanin and entered in the kinetic analysis
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of amoxicillin-clavulanic acid
From dialyser inlet and outlet samples, the extraction ratio is calculated for amoxicillin-clavulanic acid and entered in the kinetic analysis
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of piperacillin-tazobactam
From dialyser inlet and outlet samples, the extraction ratio is calculated for piperacillin-tazobactam and entered in the kinetic analysis
Time frame: 9/2016 - 12/2021
Dialyser extraction rate of ceftazidim
From dialyser inlet and outlet samples, the extraction ratio is calculated for ceftazidim and entered in the kinetic analysis
Time frame: 9/2016 - 12/2021
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.