This trial is active, not recruiting.

Condition cardiopulmonary bypass
Treatment blood and tissue sampling
Sponsor University Hospital, Ghent
Start date December 2012
End date April 2016
Trial size 56 participants
Trial identifier NCT02749981, 2012/631-632-633


Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
patients receiving cefazolin as part of routine clinical care
blood and tissue sampling

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

Eligibility Criteria

Male or female participants up to 15 years old.

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

Additional Information

Official title Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Principal investigator Katrien Francois, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.