Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

NCT ID: NCT02749981

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-10-31

Brief Summary

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Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

Detailed Description

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Conditions

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Cardiopulmonary Bypass

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Cefazolin

patients receiving cefazolin as part of routine clinical care

blood and tissue sampling

Intervention Type PROCEDURE

Interventions

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blood and tissue sampling

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katrien Francois, MD

Role: PRINCIPAL_INVESTIGATOR

Ghent University Hospital, Department of Cardiac Surgery

References

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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.

Reference Type DERIVED
PMID: 27999040 (View on PubMed)

Other Identifiers

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2012/631-632-633

Identifier Type: -

Identifier Source: org_study_id

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