Suspected Infection With Vancomycin Susceptible Bacterial Strains Clinical Trial
— PK-VANCO-ICUOfficial title:
Pharmacokinetics of Vancomycin in ICU Patients
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.
| Status | Active, not recruiting |
| Enrollment | 80 |
| Est. completion date | August 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 - myeloma - cystic fibrosis - burn injury on more than 20 % of the body surface - previous inclusion in present study |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon - Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire,103 Grande Rue de la Croix-Rousse | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration | 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 |
week 1 | No |
| Secondary | Rate of patients with under-dosage of vancomycin at day 2 of treatment | under-dosage of vancomycin is defined by a vancomycin serum concentration below 15 mg/l on day 2 of treatment. | day 2 | No |