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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how to better manage certain antibiotics, called beta-lactams, in critically ill patients who have suffered an acute brain injury. Some of these patients may experience a condition known as Augmented Renal Clearance (ARC), where their kidneys work unusually well and clear these medications from their bodies faster than normal. This can lead to lower levels of the antibiotics in the bloodstream, increasing the risk of ineffective treatment for infections. The goal of the trial is to find ways to identify patients at risk of receiving inadequate doses of these antibiotics so that their treatment can be adjusted accordingly, improving their chances of recovery.

To be eligible for the trial, participants must be adults aged 18 or older, currently in the intensive care unit for an acute brain injury, and show signs of ARC based on specific kidney function tests. They must also be receiving TDM-guided treatment with one of the specified beta-lactam antibiotics. Participants can expect a thorough assessment of their kidney function and antibiotic levels, which will help researchers develop better dosing strategies tailored to individual needs. It’s important to note that some patients, such as those with a very short life expectancy or those involved in other studies, will not be able to participate.

Gender

ALL

Eligibility criteria

• 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