Clinical trial NCT03628300: Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors
Official title: Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurotoxicity
Sepsis
Beta Lactams
Therapeutic Drug Monitoring
Critical Care
Acute Kidney Injury
Keywords: neurotoxicity
Sepsis
beta lactams
therapeutic drug monitoring
critical care
Acute Kidney Injury
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective cohort study evaluating change in neurological status of patients admitted to the ICU and treated with a beta-lactam antibiotic with therapeutic drug monitoring. Neurological evaluation and scoring (Glasgow scale, CAM-ICU, Richmond agitation-sedation scale) and beta-lactam serum concentration assay are performed together 2 to 3 times a week.

Brief summary: Beta-lactams are the most prescribed antibiotics in intensive care units. The lack of linearity between the dose administered and the exposition due to the very high variability of the pharmacokinetics in critically ill patients requires that the treatment be adapted on a case-by-case basis depending on the drug serum concentration. However, maximum concentrations not to be exceeded in order to limit beta-lactams toxicity are generally unknown. The main toxic risk of beta-lactams in intensive care is indeed neurological, but the neurotoxicity is probably underdiagnosed due to the variability of the signs observed, their time to onset, and confounding factors. Apart from recommendations for dose adjustment in the event of renal insufficiency, the procedures for the proper use of beta-lactams in intensive care are poorly established. The study presented here aims to assess the impact of the neurotoxic risk of beta-lactams in intensive care based on therapeutic drug monitoring, and thus to improve beta-lactam safety in critically ill patients.

This is a prospective cohort study evaluating change in neurological status of patients admitted to the ICU and treated with a beta-lactam antibiotic with therapeutic drug monitoring. Neurological evaluation and scoring (Glasgow scale, CAM-ICU, Richmond agitation-sedation scale) and beta-lactam serum concentration assay are performed together 2 to 3 times a week.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU
* Treatment initiation by an antibiotic of the beta-lactam class
* Beta-lactam therapeutic drug monitoring

Exclusion criteria:

* Any neurological disorder already present at admission
* Patients on mechanical ventilation who presented a neurological disorder before being intubated and sedated

Primary outcomes:
measure: proportion of patients with a change in neurological status
timeFrame: one week
Secondary outcomes:
measure: beta-lactam serum concentration according neurological status
timeFrame: one week
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Youssef Youssef, MD
role: PRINCIPAL_INVESTIGATOR
References: