Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CEFA)

May 17, 2023 updated by: University Hospital, Ghent
Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children undergoing cardiac surgery with cardiopulmonary bypass

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cefazolin
patients receiving cefazolin as part of routine clinical care
Procedure: blood and tissue sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Katrien Francois, MD, Ghent University Hospital, Department of Cardiac Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2012/631-632-633

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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