Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients (TAPAS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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amoxicillin-clavulanic acid

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 .

Intervention Type DRUG

Other Intervention Names

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meropenem flucloxacillin piperacillin-tazobactam clindamycin

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No