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

NCT03628300 | Completed

• 1 other identifier: PI2017_843_0036
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• proportion of patients with a change in neurological status

  the primary objective is to assess the frequency of beta-lactam neurotoxicity in a standardized use with therapeutic drug monitoring

  one week

Secondary Outcomes (1)

• beta-lactam serum concentration according neurological status

  one week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Neurotoxicity Syndromes; Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Youssef Youssef, MD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 14, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 29, 2022

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share