Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Fa… (NCT03628300) | Clinical Trial Compass
CompletedNot Applicable
Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors
France400 participantsStarted 2017-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on neurotoxicity from beta-lactam antibiotics in the ICU — if I'm being treated with beta-lactams for sepsis, how would my doctors monitor for signs that the antibiotic might be affecting my brain or nervous system?
2Since this study looked at therapeutic drug monitoring alongside neurological changes, is measuring beta-lactam drug levels in the blood something my care team would consider doing for me, and what would they do if my levels were too high?
3The trial specifically looked at patients with acute kidney injury as a potential risk factor — if my kidneys are not working well, does that put me at higher risk for beta-lactam-related neurotoxicity, and how would that change my treatment plan?
4Now that this trial is completed, has any of its findings about risk factors for neurological changes in ICU patients influenced how your team manages beta-lactam dosing, and would those practices apply to my care?
5If there are signs that a beta-lactam antibiotic is affecting my neurological status, what are the alternative antibiotic options my doctors could switch to for treating my infection?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
proportion of patients with a change in neurological status