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Not yet recruiting NCT07327502

Antibiotics Distribution Study in Peripheral Compartments: Contribution of Microdialysis

No phase Interventional Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Microdialysis probe placement, Microdialysis and Plasma samples.
Who it may be relevant to
Registry conditions: Children in Cardiac Intensive Care Requiring Surgery for Congenital Heart Disease. Basic parameters: 6 months — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Primary outcome measures

  • Total clearance [Time frame: 36 hours]
  • Distribution volume [Time frame: 36 hours]
  • Inter-compartmental clearance [Time frame: 36 hours]
Secondary outcome measures (2)
  • Monte Carlo simulations and dosing optimization [Time frame: 36 hours]
  • post-operative mediastinitis occurrence [Time frame: Month 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Hôpital Necker Enfants Malades — Paris

Publications

  • 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. PMID 27317707
  • 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. PMID 25527166

Identifiers

NCT: NCT07327502 · APHP241591 · 2025-521988-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗