Antibiotic Dosing in Patients on Intermittent Hemodialysis

Ghent University Hospital (UZ)

Status: Completed

Conditions: Hemodialysis; Antibiotics; Kidney Failure, Chronic

Treatments: Other: Blood and urine sampling

Study type: Observational

Funder types: Other

Identifiers

NCT03909698

UGent_ABdosing

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with end-stage kidney disease, requiring intermittent hemodialysis
• patient receiving antibiotic treatment for documented or presumed infection (vancomycin, teicoplanin, amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim)

Exclusion criteria

• pregnant woman
• absence of written informed consent from the patient
• known hypersensitivity or contra-indication to glycopeptides or beta-lactam antibiotics

Trial design

150 participants in 5 patient groups

Hemodialysis patients on amoxicillin-clavulanic acid

Description:

The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for amoxicillin-clavulanic acid.

Treatment:

Other: Blood and urine sampling

Hemodialysis patients on ceftazidim

Description:

The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for ceftazidim.

Treatment:

Other: Blood and urine sampling

Hemodialysis patients on piperacillin-tazobactam

Description:

The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for piperacillin-tazobactam.

Treatment:

Other: Blood and urine sampling

Hemodialysis patients on vancomycin

Description:

The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for vancomycin.

Treatment:

Other: Blood and urine sampling

Hemodialysis patients on teicoplanin

Description:

The antibiotic administration protocol is not changed for this study. From the first administration on, administrations (dosage and duration) are well documented. Blood samples are taken as peak, distribution and trough samples during at least 24 or 48 hours. During the first dialysis session after study start, blood samples are also taken from the arterial and venous blood line simultaneously and at different dialysis time points, to calculate dialyzer extraction ratio. When appropriate, urine is collected during a documented period. During the second dialysis after study start, arterial and venous samples are taken for different dialysis settings, in order to calculate extraction ratios for different settings. All blood and urine samples are analyzed for teicoplanin.

Treatment:

Other: Blood and urine sampling