Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid
研究概览
简要总结
Therapeutic drug monitoring of antibiotics in critically ill patients is a present research topic of the last ten years. Research results have shown subtherapeutic blood concentrations in those patients. However, the amount of antibiotics in the cerebrospinal fluid (CSF) in patients with ventriculitis or meningitis is still unclear. This study is a prospective study to evaluate the concentration of different antibiotics in the CSF in patients with an external ventricular drainage compared to antibiotic blood concentration.
详细描述
Bacterial infections are still associated with a high mortality in intensive care unit patients. Especially patients diagnosed with ventriculitis caused by a bacterial infection have a bad outcome. Therefore, antibiotic therapy is the only causal opportunity to treat those infections. However, there are many chances in pharmacokinetic and -dynamic in critically ill patients with unpredictable antibiotic concentrations. Furthermore, it is important that the concentration in the blood as well as in the effect-compartment "CSF" is sufficient. Less data of the last years describe antibiotic concentrations in the CSF and show subtherapeutic levels, which is endangering for the therapeutic success. The introduced study is a prospective, observational study that analyses antibiotic concentrations in CSF in critically ill patients. The distribution between CSF and blood will be evaluated by comparing these two compartments.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written approval of the legal guardian
- •external ventricular drainage
- •antibiotic therapy
排除标准
- •no approval
- •no antibiotic therapy or no external ventricular drainage
结局指标
主要结局
Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid
时间窗: through study completion, on average 2 years
Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis
次要结局
- 28-day mortality(through study completion, on average 2 years)
- Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein(through study completion, on average 2 years)
- Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6(through study completion, on average 2 years)
研究者
Michael Zoller MD
senior physician, Department of Anaesthesiology, university hospital munich
Ludwig-Maximilians - University of Munich