Cefazolin Dosing in Children Undergoing Cardiac Surgery W... | NCT02749981

Studies
Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

NCT02749981

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

May 18, 2023Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Cardiopulmonary Bypass

Interventions

blood and tissue sampling

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Apr 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Oct 20, 2015

First Submission Date that Met QC Criteria

Apr 22, 2016

First Posted Date

Apr 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2023

Last Update Posted Date

May 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cefazolin		patients receiving cefazolin as part of routine clinical care	Procedure: blood and tissue sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood and tissue sampling	Procedure		Cefazolin

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

15 Years

Standard Ages

Child

Study Population

children undergoing cardiac surgery with cardiopulmonary bypass

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katrien Francois, MD	Ghent University Hospital, Department of Cardiac Surgery	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27999040	Derived	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.

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis