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NCT Number: NCT07327502

Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis

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.

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microdialysis probe placement

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

Procedure

26 Cefazolin Free tissue concentrations 6 total plasma concentrations

Primary outcomes

  1. Total clearance

    Time frame: 36 hours

    Pharmacokinetics of cefazolin total clearance in children after cardiac surgery and inter-individual variability.

  2. Distribution volume

    Time frame: 36 hours

    Pharmacokinetics of cefazolin distribution volume in children after cardiac surgery and inter-individual variability.

  3. Inter-compartmental clearance

    Time frame: 36 hours

    Pharmacokinetics of cefazolin inter-compartmental clearance in children after cardiac surgery and inter-individual variability.

Secondary outcomes

  1. Monte Carlo simulations and dosing optimization

    Time frame: 36 hours

    Monte Carlo simulations performed using the model with SimulX (version 2024R1) and R (version 4.4.2) softwares. Probability of attainment of PK/PD target (100 % ƒT > 4xCMI) with simulated dosing regimens No patient data is required for this step.

  2. post-operative mediastinitis occurrence

    Time frame: Month 1

    Assess the relationship between tissue exposure and clinical outcome: occurrence of post-operative mediastinitis

Study contacts

Contact information is provided by the study sponsor or research team.

Gael Plastow

CONTACT

[email protected]

01 44 38 18 57 ext. +33

Noemie De Cacqueray, MD

CONTACT

[email protected]

07 50 91 72 02 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: Antimidis

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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