Pharmacokinetics/Pharmacodynamics and Therapeutic Drug Monitoring of Novel β-lactams and β-lactamase Inhibitors in Critically Ill Patients Undergoing Extracorporeal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary aim
研究概览
简要总结
The aim of this study is to comparatively evaluate serum concentrations of continuously applied antibiotics in ICU patients, with and without ECMO/RRT support.
详细描述
Among all patients being treated with new generation antibiotics (beta.lactams and beta-lactamase inhibitors), we will take into consideration the results of those admitted to intensive care units.
Effective antimicrobial treatment is critical to reduce their mortality associated with bacterial sepsis. They often also require extracorporeal supports, such as renal replacement therapy (RRT) and extracorporeal membrane oxygenation (ECMO), for their survival. However, few studies, limited only to some drugs, report the importance of therapeutic drug monitoring for adequate dose adjustment in these particular conditions of extracoporeal support.
The risk of reaching sub therapeutic or toxic levels is quite high, due to possible very significant variations in the pharmacokinetics of the drugs because of their interaction with the various components of the ECMO and RRT devices, the characteristics of the drug itself and the pathophysiological changes of the patients on ECMO and/or RRT.
Primary aim is to evaluate whether the standard prescriptions of beta lactams/beta lactamase inhibitors (BL/BLIs) are adequate to achieve the optimal PK/PD target also for ECMO and RRT (or combined) patients admitted to intensive care unit.
Secondary aims include to evaluate:
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
- •adult patients (age 18y or older)
- •admitted to ICU
- •supported or not-supported with extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy (RRT)
- •affected by gram-negative bacterial infections susceptible to the novel antibiotics.
排除标准
- •Pediatric age (<18y)
- •allergies to pharmaceutical and/or inactive drug ingredients (excipients)
- •life expectancy less than 1 month
- •body mass index (BMI) >45 kg/m2
- •pregnancy
结局指标
主要结局
Primary aim
时间窗: up to 24 months
evaluate whether the standard prescriptions of beta lactams/beta lactamase inhibitors (BL/BLIs) are adequate to achieve the optimal PK/PD target also for ECMO and RRT (or combined) patients admitted to intensive care unit.
次要结局
- occurrence of sub-therapeutic and/or toxic drugs levels(up to 24 months)
- proportion of patients with insufficient drugs levels in different subgroups(up to 24 months)
- proportion of patients with toxic or sub-therapeutic drugs levels in the same subgroups(up to 24 months)
- proportion, when possible, of drugs level before and during the extracorporeal therapy, for the same patient(up to 24 months)
- occurrence of drug resistance by pathogens and their mechanism(up to 24 months)
研究者
Simona De Gregori
PhD in Chemical Sciences
Fondazione IRCCS Policlinico San Matteo di Pavia