Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- vancomycin and cefoxitin concentration change in serial plasmatic samples
研究概览
简要总结
The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata: neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.
详细描述
Few data are available in current literature about pharmacokinetics (PK) of antibiotics administered as surgical prophylaxis to children scheduled for cardiac surgery with CPB. In particular, vancomycin PK during CPB has been studied only in small case series, whereas no specific study has been conducted, so far, in the specific setting of children receiving cefoxitin during CPB.
CPB affects patients' volemia and drugs PK is eventually altered. On the other side during and after surgery for heart defects, many risk factors may decrease renal and hepatic clearance, including altered renal perfusion, use of vasoactive agents, and use of concomitant nephrotoxic medications.
Primary Objective of the study will be:
• To study the pharmacokinetic profile of vancomycin and cefoxitin administered, as antibiotic prophylaxis to children undergoing elective CPB.
Secondary Objectives will be:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective cardiac surgery schedule with the planned application of CPB
- •Parents of neonates, or their legal representative, able to consent and comply with protocol requirements.
排除标准
- •Urgent or emergent surgery
- •Antibiotic therapy (any) administered before surgery
- •Patients receiving, before surgery, any other ofr of extracorporeal treatment (i.e extracorporeal membrane oxygenation, continuous renal replacement therapy)
- •Previous renal or hepatic dysfunction requiring need for antibiotic posology modification.
- •Surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin)
- •extremely low birth weight neonates.
结局指标
主要结局
vancomycin and cefoxitin concentration change in serial plasmatic samples
时间窗: samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2), at end of surgery.
a 4-points pharmacokinetic curve per each antibiotic will be generated by serial average plasmatic vancomycin and cefoxitin concentration assessments.
次要结局
- differences between pre-determined subgroups (neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg) in plasmatic vancomycin and cefoxitin levels change at each time point(samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2).)
- vancomycin and cefoxitin clearance by ultrafiltration(Ultrafiltrate sample will be withdrawn at the end of CPB (UF1))
研究者
Zaccaria Ricci
Medical Doctor
Bambino Gesù Hospital and Research Institute