Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 10 people, planned
- Started
- Jan 2026
- Expected to end
- Feb 2027
- Type of study
- Interventional
- Treatments tested
- Microdialysis probe placement
- Microdialysis and Plasma samples
- Record updated
- 8 January 2026
Who can take part
- Age
- 6 months to 6 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Child aged over 6 months and under 6 years
- Hospitalized in pediatric cardiac intensive care after cardiac surgery for congenital heart disease
- Selected congenital heart diseases: ventricular septal defect auricular septal defect, pulmonary stenosis, tetralogy of Fallot
- Surgery with median sternotomy and intraoperative cardiopulmonary bypass
- Intraoperative antibiotic prophylaxis with cefazolin
- Patient affiliated with a social security plan or eligible
- whose two parents or legal guardians have accepted and signed the study consent
Who cannot take part
- Patient who has previously undergone cardiac surgery
- Emergency cardiac surgery
- Patient with haemostasis disorders or immune deficiency
- Patient already enrolled in the study
- Patient with bacterial colonization indicating antibiotic prophylaxis other than cefazolin
- Participation in another interventional research study
Where in France
- Hopital Necker Enfants MaladesParis, FranceContact: Margaux Pontailler, MDNo longer taking part
About the trial
What the trial wants to find out
Postoperative mediastinitis is an important cause of postoperative morbidity in children. The main objective of this study is to describe the distribution of cefazolin, using as surgical antibiotic prophylaxis, in the mediastinal compartment in children after cardiac surgery for congenital heart disease. The investigators aims to build a population pharmacokinetic model of cefazolin using plasma and tissue concentrations in order to optimize and individualize cefazolin dosing regimens. Cefazolin tissue pharmacokinetics will use a microdialysis procedure.
The group in the trial
- Cefazolin measurementsTreatment being tested
Microdialysis probe placement and blood drawings to measure cefazolin concentration in mediastinum tissue and in plasma.
Treatment: Microdialysis probe placement and Microdialysis and Plasma samples
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cefazolin Distribution in Mediastinum After Heart Surgery in Children Using a Microdialysis Probe.
- Record updated
- 8 January 2026