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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Brain Injuries; Critical Illness

Study type: Observational

Funder types: Other

Identifiers

NCT06999161

LOCAL/2025/CR-01

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 1 patient group

BETALACTAM Treated Patients

Description:

Adult patients (≥18 years) admitted to intensive care for acute brain injury, presenting with an infectious episode, documented augmented renal clearance (as assessed by urinary creatinine clearance), and receiving treatment with beta-lactam antibiotics.