Cefazolin Distribution in Mediastinum After Heart Surgery in Children Using a Microdialysis Probe.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Total clearance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Total clearance
时间窗: 36 hours
Pharmacokinetics of cefazolin total clearance in children after cardiac surgery and inter-individual variability.
Inter-compartmental clearance
时间窗: 36 hours
Pharmacokinetics of cefazolin inter-compartmental clearance in children after cardiac surgery and inter-individual variability.
Distribution volume
时间窗: 36 hours
Pharmacokinetics of cefazolin distribution volume in children after cardiac surgery and inter-individual variability.
次要结局
- Monte Carlo simulations and dosing optimization(36 hours)
- post-operative mediastinitis occurrence(Month 1)