Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients BETALACTACRIT

NCT06596096

Sepsis

COMPLETED

Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients

NCT06338345

Cardiogenic Shock Post-cardiac Surgery Cardiac Arrest +2 more

NOT_YET_RECRUITING NA

The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients

NCT02446392

Sepsis

COMPLETED

Pharmacokinetic of Ceftriaxone in Septic ICU Patients

NCT00449800

Sepsis Severe Sepsis Septic Shock

UNKNOWN PHASE4

Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit

NCT03217721

Neutropenia, Febrile

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurotoxicity Sepsis Beta Lactams Therapeutic Drug Monitoring Critical Care Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No