NCT07067736招募中不适用
Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid(CSF) Concentration During Valve Implantation
University Hospital, Strasbourg, France3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Cefazolin concentration in the cerebrospinal fluid
研究概览
简要总结
The objective is to determine the concentration of cefazolin in the cerebrospinal fluid after a recommended antiobiotic prophylaxis by 2g of cefazolin. Our main hypothesis is that the concentration is insufficient to protect the valve from infections.
The secondary objective is to compare our results to known pharmacokinetic models of cefazolin diffusion in the literature. If differences are found we would like to search clinical features that could explain it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years and programmed for a ventricular shunt surgery at the Hautepierre university hospital in Strasbourg.
排除标准
- •Age <18 years old
- •Pregnant women
- •Infected patients
- •Known cefazolin allergy
- •Other molecule used for the antibiotic prophylaxis
- •Guardianship or conservatorship
- •Patients under curative antibiotherapy
- •Non sterile pre operative CSF
- •Refusal to participate
研究组 & 干预措施
Cefazolin antibiotic prophylaxis in ventricular shunt surgery
Experimental
干预措施: Cefazolin antibiotic prophylaxis (Other)
结局指标
主要结局
Cefazolin concentration in the cerebrospinal fluid
时间窗: The measure is made when the dura mater is opened just before the valve implantation.
Cefazolin concentration in the cerebrospinal fluid.
次要结局
- blood cefazolin concentration(Blood samples are made 2 hours after injection)
研究者
研究点 (3)
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