Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
Recruiting now
Conditions studied: Critical Illness, Brain Injuries
In brief
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.
Key facts
- Study ID
- NCT06999161
- Run by
- Centre Hospitalier Universitaire de Nīmes
- People needed
- 140
- Starts
- 2025-05-05
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-05-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHU de Nîmes - Hôpital Universitaire Carémeau — Nîmes, France (enrolling)
Full record on ClinicalTrials.gov
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