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Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury

Recruitingn/aAges 18 Years - anyAllCentre Hospitalier Universitaire de Nīmes
NCT06999161 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 par

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

1 site
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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