Actively Recruiting

Age: 18Years +
All Genders
NCT06999161

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France, 30029

Actively Recruiting

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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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