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NOT YET RECRUITING
NCT07327502
NA

Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Cefazolin Distribution in Mediastinum After Heart Surgery in Children Using a Microdialysis Probe.

Key Details

Gender

All

Age Range

6 Months - 6 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-01

Completion Date

2027-02

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

PROCEDURE

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.

PROCEDURE

Microdialysis and Plasma samples

26 Cefazolin Free tissue concentrations 6 total plasma concentrations

Locations (1)

Hôpital Necker Enfants Malades

Paris, Île-de-France Region, France