Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Cardiopulmonary Bypass Clinical Trial

— CEFA  

Official title:

Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749981
• Other study ID #: 2012/631-632-633
• Status: Completed
• Start date: December 2012
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

Procedure:
• blood and tissue sampling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Outcome

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