Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Correlation of meropenem concentration in serum to the concentration in brain fluid
研究概览
简要总结
Therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. Based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany. This study is an prospective evaluation of these TDM-program.
详细描述
Bacterial infections are associated with high mortality in intensive care patients. Antibiotic therapy is the only causal opportunity to treat those infections. Pharmacokinetic and -dynamic changes in critically ill patients lead to unpredictable plasma concentrations of the applied drugs. Research results of the last years with many quantified plasma concentrations in subtherapeutic levels yield to the recommendation of the Paul-Ehrlich-Society for an routines therapeutic drug monitoring of antibiotics in intensive care patients. These was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany for all intensive care patients as a routines procedure. The introduced study is a prospective evaluation of the TDM-program with regard to improvement opportunity, influencing factors and parallels to other studies.
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
- •routines TDM of antiinfectives
排除标准
- •TDM is not available
结局指标
主要结局
Correlation of meropenem concentration in serum to the concentration in brain fluid
时间窗: during the treatment with an external ventricular drainage
The concentration of meropenem in the brain fluid of 30 patients with an external ventricular drainage will be correlated to their serum concentration
Incidence of subtherapeutic antiinfective concentrations
时间窗: four years
Number of subtherapeutic concentrations from different antiinfectives in critically ill patients
Subtherapeutic antiinfective concentrations during hemoadsorption
时间窗: during hemoadsorption treatment
Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment
次要结局
- 28-day mortality of patients with therapeutic drug monitoring of antiinfectives(during intensive care treatment)
- ICU-free days of patients with therapeutic drug monitoring of antiinfectives(during intensive care treatment)
- Sofa-score course of patients with therapeutic drug monitoring of antiinfectives(during the treatment with the antiinfectives)
- Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives(during the treatment with the antiinfectives)
- Time course of CRP in patients with therapeutic drug monitoring of antiinfectives(during the treatment with the antiinfectives)
研究者
Michael Zoller MD
Principal Investigator
Ludwig-Maximilians - University of Munich