Cardiopulmonary BypassCEFANCT02749981
Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
An observational study of Cardiopulmonary Bypass, run by University Hospital, Ghent.
Trial summary
Pharmacokinetics of cefazolin in children undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 0 days to 15 years
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- blood and tissue sampling
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children undergoing cardiac surgery with cardiopulmonary bypass
Who may be able to join
- 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)
Who cannot join
- no catheter in place for blood sampling
- absence of parental/patient consent
- known hypersensitivity to cefazolin
About this study
Pharmacokinetics of cefazolin in children undergoing cardiac surgery.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- blood and tissue sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and tissue samplingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | patients receiving cefazolin as part of routine clinical care Receives: Procedure: blood and tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the time during which the unbound cefazolin concentration is above the MIC of S. aureus (fT>MIC) with the current dosing regimen
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startDec 2012
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrien Francois, MD, Principal investigator, Ghent University Hospital, Department of Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749981
- Sponsor's protocol ID
- 2012/631-632-633
- Acronym
- CEFA
- Status last verified
- May 2017
- First submitted
- 20 Oct 2015
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27999040
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02749981
- Acronym / sponsor ID
- CEFA / 2012/631-632-633
- Conditions
- Cardiopulmonary Bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacokinetics of cefazolin in children undergoing cardiac surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | – | Procedure: blood and tissue samplingpatients receiving cefazolin as part of routine clinical care |
Who may qualify
- Ages
- 0 days to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children undergoing cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- no catheter in place for blood sampling
- absence of parental/patient consent
- known hypersensitivity to cefazolin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and tissue sampling | Procedure or surgery | Cefazolin |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 27999040De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrien Francois, MD principal investigator
Ghent University Hospital, Department of Cardiac Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass, run by University Hospital, Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02749981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.