An interventional study of Microdialysis probe placement and Microdialysis and Plasma samples in Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science
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.
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.
21 studies on the registry are indexed under Mediastinitis; 3 are open to participants now.
This study's planned enrollment of 10 is below the median of 83 across 12 interventional studies indexed under Mediastinitis.
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Microdialysis probe placement and blood drawings to measure cefazolin concentration in mediastinum tissue and in plasma.
Procedure: Microdialysis probe placement · Procedure: Microdialysis and Plasma samples
Microdialysis probe is placed at the end of cardiac surgery in mediastinum and used during 36 hours for tissue samples until withdrawal.
26 Cefazolin Free tissue concentrations 6 total plasma concentrations
Total clearance
Pharmacokinetics of cefazolin total clearance in children after cardiac surgery and inter-individual variability.
Time frame: 36 hours
Distribution volume
Pharmacokinetics of cefazolin distribution volume in children after cardiac surgery and inter-individual variability.
Time frame: 36 hours
Inter-compartmental clearance
Pharmacokinetics of cefazolin inter-compartmental clearance in children after cardiac surgery and inter-individual variability.
Time frame: 36 hours
Monte Carlo simulations and dosing optimization
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.
Time frame: 36 hours
post-operative mediastinitis occurrence
Assess the relationship between tissue exposure and clinical outcome: occurrence of post-operative mediastinitis
Time frame: Month 1
Plan to share: No
Start is estimated for Jan 2026; primary completion for Feb 2026, 1 month later.
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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