Hôpital Necker Enfants Malades
Paris, Île-de-France Region, 75015, France
NCT Number: NCT07327502
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.
Trial opening soon.
Get Notified6 month–6 year
All sexes
Interventional
Not applicable
Paris, Île-de-France Region, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 36 hours
Pharmacokinetics of cefazolin total clearance in children after cardiac surgery and inter-individual variability.
Time frame: 36 hours
Pharmacokinetics of cefazolin distribution volume in children after cardiac surgery and inter-individual variability.
Time frame: 36 hours
Pharmacokinetics of cefazolin inter-compartmental clearance in children after cardiac surgery and inter-individual variability.
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.
Time frame: Month 1
Assess the relationship between tissue exposure and clinical outcome: occurrence of post-operative mediastinitis
Contact information is provided by the study sponsor or research team.
Gael Plastow
CONTACT
01 44 38 18 57 ext. +33
Noemie De Cacqueray, MD
CONTACT
07 50 91 72 02 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Cefazolin Distribution in Mediastinum After Heart Surgery in Children Using a Microdialysis Probe.
Acronym: Antimidis
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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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