Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis

NCT ID: NCT07327502

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-02-28

Brief 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.

Detailed Description

Children with congenital heart disease are very fragile during the postoperative period and at risk of life-threatening mediastinitis due to various factors: post-extracorporeal circulation inflammation, frequent organ failure, possible delayed thorax closure. These patients are at risk of unpredictable pharmacokinetics alteration and inter-individual variability of the drug tissue: significant fluid intake, drug metabolism and elimination functions alteration, extracorporeal circulation. The effective prevention of postoperative mediastinitis in this population is therefore a major issue and challenge. Studying the distribution of cefazolin in the mediastinum and identifying the factors of inter-individual variability would improve the prevention of this pathology by optimizing the dosing.

During cardiac surgery, a microdialysis probe is placed by the surgeon in the mediastinum. The outgoing fluid will be collected every 30 minutes to every 2 hours, for approximately 28 hours. Six plasma samples will be drawn over these 28 hours to measure plasma concentrations. The probe's recovery will then be calculated and the probe will be removed up to 36 hours after insertion.

Conditions

Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cefazolin measurements

Microdialysis probe placement and blood drawings to measure cefazolin concentration in mediastinum tissue and in plasma.

Group Type: EXPERIMENTAL

Microdialysis probe placement

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

26 Cefazolin Free tissue concentrations 6 total plasma concentrations

Interventions

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.

Intervention Type: PROCEDURE

Microdialysis and Plasma samples

26 Cefazolin Free tissue concentrations 6 total plasma concentrations

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaux Pontailler, MD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker Enfants Malades

Paris, Île-de-France Region, France

Countries

France

Central Contacts

Noemie De Cacqueray, MD

Role: CONTACT

noemie.decacquerayvalmenier@aphp.fr

07 50 91 72 02 ext. +33

Gael Plastow

Role: CONTACT

gael.plastow@aphp.fr

01 44 38 18 57 ext. +33

Facility Contacts

Margaux Pontailler, MD

Role: primary

margaux.pontailler@aphp.fr

01 71 39 65 72 ext. +33

Gael PLASTOW

Role: backup

gael.plastow@aphp.fr

01 44 38 18 57 ext. +33

References

Himebauch AS, Sankar WN, Flynn JM, Sisko MT, Moorthy GS, Gerber JS, Zuppa AF, Fox E, Dormans JP, Kilbaugh TJ. Skeletal muscle and plasma concentrations of cefazolin during complex paediatric spinal surgery. Br J Anaesth. 2016 Jul;117(1):87-94. doi: 10.1093/bja/aew032.

Reference Type: BACKGROUND

PMID: 27317707 (View on PubMed)

Andreas M, Zeitlinger M, Wisser W, Jaeger W, Maier-Salamon A, Thalhammer F, Kocher A, Hiesmayr JM, Laufer G, Hutschala D. Cefazolin and linezolid penetration into sternal cancellous bone during coronary artery bypass grafting. Eur J Cardiothorac Surg. 2015 Nov;48(5):758-64. doi: 10.1093/ejcts/ezu491. Epub 2014 Dec 18.

Reference Type: BACKGROUND

PMID: 25527166 (View on PubMed)

Other Identifiers

2025-521988-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APHP241591

Identifier Type: -

Identifier Source: org_study_id