Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis

NCT07327502 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2026-01

Last updated

2026-01-08

Condition(s) studied

Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease

Investigational drug(s) / intervention(s)

Microdialysis probe placementMicrodialysis and Plasma samples

Microdialysis probe placement: Microdialysis probe is placed at the end of cardiac surgery in mediastinum and used during 36 hours for tissue samples until withdrawal.

Microdialysis and Plasma samples: 26 Cefazolin Free tissue concentrations 6 total plasma concentrations

Study summary

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.

Eligibility

Sex

ALL

Min age

6 Months

Max age

6 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * Emergency cardiac surgery * Patient already enrolled in the study * Patient who has previously undergone cardiac surgery * Patient with haemostasis disorders or immune deficiency * Patient with bacterial colonization indicating antibiotic prophylaxis other than cefazolin * Participation in another interventional research study

Primary outcome measure(s)

Total clearance — 36 hours
Pharmacokinetics of cefazolin total clearance in children after cardiac surgery and inter-individual variability.
Distribution volume — 36 hours
Pharmacokinetics of cefazolin distribution volume in children after cardiac surgery and inter-individual variability.
Inter-compartmental clearance — 36 hours
Pharmacokinetics of cefazolin inter-compartmental clearance in children after cardiac surgery and inter-individual variability.

Trial sites (1)

Facility	City	Region	Status
Hôpital Necker Enfants Malades	Paris	Île-de-France Region

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327502 on ClinicalTrials.gov ↗ ← All trials in France