Monitoring beta-lactam antibiotics and kidney clearance in ICU patients with acute brain injury
Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
This project tries to see if checking kidney clearance together with blood drug levels can quickly identify ICU patients with acute brain injury who need higher doses of beta-lactam antibiotics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT06999161 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults admitted to the intensive care unit for acute brain injury who receive TDM-guided treatment with specified beta-lactam antibiotics. Investigators will record urinary creatinine clearance to identify augmented renal clearance (ClCrU >130 mL/min/1.73 m²) and pair those measurements with beta-lactam plasma concentrations. No experimental interventions are given; data are used to describe pharmacokinetics and the relationship between renal clearance and drug levels. The goal is to produce datasets that could support predictive models for individualized dosing decisions.
Who should consider this trial
Good fit: Adults (≥18) admitted to the ICU for acute brain injury who show augmented renal clearance (>130 mL/min/1.73 m²) and are receiving one of the listed beta-lactam antibiotics with TDM.
Not a fit: Patients with life expectancy under 24 hours, those under legal protection, those who decline participation, or patients not receiving the specified beta-lactams or without ARC are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this could help clinicians spot patients whose kidneys clear beta-lactams too quickly so doses can be adjusted to avoid underdosing and treatment failure.
How similar studies have performed: Therapeutic drug monitoring has been shown to improve beta-lactam target attainment in critically ill patients, but combining systematic renal clearance measurements with TDM to build predictive models specifically in acute brain injury is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nîmes
- CHU de Nîmes - Hôpital Universitaire Carémeau — Nîmes, France (Recruiting)
Study contacts
- Study coordinator: Claire ROGER, MD, pHD
- Email: claire.roger@chu-nimes.fr
- Phone: +33 466683331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.