Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Plasma betalactam underdosing
研究概览
简要总结
Augmented Renal Clearance (ARC), defined as a supraphysiological increase in renal function, is frequently observed in critically ill patients, particularly those with acute brain injury. ARC complicates the management of renally eliminated drugs, specifically beta-lactam antibiotics, by enhancing drug clearance and thereby increasing the risk of underdosing and therapeutic failure. Although pharmacological therapeutic drug monitoring (TDM) is recommended to optimize dosing, it remains limited by issues of accessibility, highlighting the need for alternative approaches to identify at-risk patients and adjust dosing based on renal function.
Early identification of patients at risk for subtherapeutic beta-lactam plasma concentrations could enable timely dose adjustments. A combined assessment of renal function and beta-lactam TDM could enhance our understanding of the kinetics of both parameters. These data may support the development of predictive models capable of proposing individualized dosing regimens based on renal function.
Optimizing beta-lactam plasma concentrations in this patient population could improve infection management and potentially enhance clinical outcomes.
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 (≥18 years old)
- •Admitted to the intensive care unit for acute brain injury
- •Exhibiting Augmented Renal Clearance (ARC), defined by a urinary creatinine clearance (ClCrU) greater than 130 mL/min/1.73 m² on at least one measurement
- •Receiving Therapeutic Drug Monitoring (TDM)-guided treatment with one of the following beta-lactam antibiotics: amoxicillin/clavulanic acid, cefotaxime, piperacillin/tazobactam, cefepime, or meropenem
- •Affiliated with or benefiting from a health insurance scheme
排除标准
- •Estimated life expectancy <24 hours
- •Patients who have expressed opposition to study participation
- •Patients under legal protection (guardianship, curatorship, or court protection)
- •Patients currently in an exclusion period determined by participation in another study
- •Patients already enrolled in a study that precludes concurrent participation in an observational study
结局指标
主要结局
Plasma betalactam underdosing
时间窗: 24 hours after the start of antibiotic therapy, and repeated every 48 hours or in the event of underdosing, overdosing, change of molecule or significant variation in renal function, assessed until the antibiotic therapy is stopped, for up to 14 days
Development of a predictive model for plasma beta-lactam underdosing in critically ill patients with acute brain injury and renal hyperclearance, receiving beta-lactam therapy for an ongoing infectious episode. Plasma beta-lactam concentrations will be measured 24 hours after initiation of antibiotic therapy, and subsequently every 48 hours, or in cases of underdosing, overdosing, antibiotic switch, or significant changes in renal function.
次要结局
- Evolution of Augmented Renal Clearance(From date of inclusion until the date of discharge from intensive care, assessed up to 28 days)
- Evolution of plasma Beta-lactam Concentration(From date of inclusion until the date of discharge from intensive care, assessed up to 28 days)
- Relationship Between Plasma Underdosing Intensity and Level of Augmented Renal Clearance (ARC)(From date of inclusion until the date of discharge from intensive care, assessed up to 28 days)
- Beta-lactam Dosing According to Augmented Renal Clearance Level.(From date of inclusion until the date of discharge from intensive care, assessed up to 28 days)
- Clinical outcome(From date of inclusion until the date of discharge from intensive care, assessed up to 28 days)