Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02749981

Acronym

CEFA

Enrollment

Registered

2016-04-25

Start date

2012-12-31

Completion date

2016-10-31

Last updated

2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Bypass

Brief summary

Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

Interventions

PROCEDUREblood and tissue sampling

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessment of the time during which the unbound cefazolin concentration is above the MIC of S. aureus (fT>MIC) with the current dosing regimen	3 years

Secondary

Measure	Time frame
Optimalisation of the cefazolin dosing regimen to aim for a target unbound cefazolin concentration above the MIC of S. aureus during surgery	3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026