EUCTR2016-004800-71-IT进行中（未招募）1 期
Determination of intraoperative levels of Cefoxitin during cardiac surgery requiring cardiopulmonary bypass in neonates, infants, children below, and above 40 kg.
Bambino Gesù Children's Hospital0 个研究点目标入组 40 人开始时间: 2016年12月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Elective cardiac surgery schedule with the planned application of CPB.
- •-Parents of elegible children, or their legal representative, able to consent and comply with protocol requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Urgent or emergent surgery
- •-Antibiotic therapy (any) administered before surgery
- •-Patients receiving, before surgery, any other form of extracorporeal treatment (i.e ECMO, CRRT)
- •-Previous renal or hepatic dysfunction requiring need for antibiotic posology modification.
- •-Surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin)
- •-ELBW neonates.
研究者
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