Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

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Key information

Conditions

Cardiopulmonary Bypass

Age range

0 day–15 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and tissue sampling

Procedure

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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: CEFA

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Apr 25, 2016
Registry last updated: May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed