NCT02749981

Brief Summary

Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2017

Enrollment Period

3.3 years

First QC Date

October 20, 2015

Last Update Submit

May 17, 2023

Conditions

Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    3 years

Study Arms (1)

Cefazolin

patients receiving cefazolin as part of routine clinical care

Procedure: blood and tissue sampling

Interventions

blood and tissue samplingPROCEDURE
Cefazolin

Eligibility Criteria

Age0 Days - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children undergoing cardiac surgery with cardiopulmonary bypass

You may qualify if:

  • 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)

You may not qualify if:

  • no catheter in place for blood sampling
  • absence of parental/patient consent
  • known hypersensitivity to cefazolin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • De Cock PA, Mulla H, Desmet S, De Somer F, McWhinney BC, Ungerer JP, Moerman A, Commeyne S, Vande Walle J, Francois K, Van Hasselt JG, De Paepe P. Population pharmacokinetics of cefazolin before, during and after cardiopulmonary bypass to optimize dosing regimens for children undergoing cardiac surgery. J Antimicrob Chemother. 2017 Mar 1;72(3):791-800. doi: 10.1093/jac/dkw496.

    PMID: 27999040DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and tissue samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Katrien Francois, MD

    Ghent University Hospital, Department of Cardiac Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

April 25, 2016

Study Start

December 1, 2012

Primary Completion

April 1, 2016

Study Completion

October 1, 2016

Last Updated

May 18, 2023

Record last verified: 2017-05