Actively Recruiting
Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-05-31
140
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years old or older)
- Admitted to the intensive care unit for acute brain injury
- Have Augmented Renal Clearance, defined by urinary creatinine clearance greater than 130 mL/min/1.73 m² on at least one measurement
- Receiving therapeutic drug monitoring-guided treatment with amoxicillin/clavulanic acid, cefotaxime, piperacillin/tazobactam, cefepime, or meropenem
- Affiliated with or benefiting from a health insurance scheme
You will not qualify if you...
- Estimated life expectancy less than 24 hours
- Patients who have expressed opposition to study participation
- Patients under legal protection such as guardianship, curatorship, or court protection
- Patients currently within an exclusion period due to participation in another study
- Patients already enrolled in a study that prevents concurrent participation in an observational study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029
Actively Recruiting
Research Team
C
Claire ROGER, MD, pHD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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