Status:

RECRUITING

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

Lead Sponsor:

Centre Hospitalier Universitaire de Nīmes

Conditions:

Critical Illness

Brain Injuries

Eligibility:

All Genders

18+ years

Brief Summary

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 complica...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 5 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

140 Patients enrolled

Trial Details

Trial ID

NCT06999161

Start Date

May 5 2025

End Date

December 1 2025

Last Update

May 31 2025

Active Locations (1)

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1

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France, 30029