Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

N/ACompletedNCT02749981

University Hospital, Ghent56 enrolled

Overview

Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiopulmonary Bypass

Interventions

blood and tissue samplingPROCEDURE

Eligibility

Sex: ALLMin age: 0 DaysMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pediatric patients undergoing cardiac surgery with cardiopulmonary bypass * minimum weight 1.8 kg * intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred) Exclusion Criteria: * no catheter in place for blood sampling * absence of parental/patient consent * known hypersensitivity to cefazolin

Outcomes

Primary Outcomes

Assessment of the time during which the unbound cefazolin concentration is above the MIC of S. aureus (fT>MIC) with the current dosing regimen

Time frame: 3 years

Secondary Outcomes

Optimalisation of the cefazolin dosing regimen to aim for a target unbound cefazolin concentration above the MIC of S. aureus during surgery

Time frame: 3 years

Data from ClinicalTrials.gov

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