Pharmacokinetics of Vancomycin in ICU Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration
Study Overview
Brief Summary
Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution, vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin underdosing in ICU patients, among others.
To date, bedside estimation of vancomycin volume of distribution is challenging, and new methods for optimizing drug administration are required.
The Picco device is a moderately invasive hemodynamic monitoring system, providing parameters that may help estimation of vancomycin pharmacokinetics parameter.
The aim of this study is to test whether addition of hemodynamic parameters would improve pharmacokinetics modelling of vancomycin concentration in ICU patients.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patient hospitalized in intensive care unit
- •under intravenous vancomycin started during current ICU hospitalization
- •with at least one vancomycin serum concentration available
- •under hemodynamic monitoring with the Picco ® device
Exclusion Criteria
- •vancomycin treatment for less than 24 hours
- •vancomycin concentration in serum unavailable
- •rare comorbidities influencing vancomycin pharmacokinetics
- •cystic fibrosis
- •burn injury on more than 20 % of the body surface
- •previous inclusion in present study
Outcomes
Primary Outcomes
Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration
Time Frame: week 1
All available vancomycin measurements during the first week of treatment will be included in the pharmacokinetics model. All vancomycin dosages up to seven days of treatment will be used in a population pharmacokinetic model and an individual pharmacokinetic model
Secondary Outcomes
- Rate of patients with under-dosage of vancomycin at day 2 of treatment(day 2)