Overview

This trial is active, not recruiting.

Condition suspected infection with vancomycin susceptible bacterial strains
Sponsor Hospices Civils de Lyon
Start date October 2015
End date July 2016
Trial size 80 participants
Trial identifier NCT02844192, 69HCL16_0452

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective

Primary Outcomes

Measure
Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration
time frame: week 1

Secondary Outcomes

Measure
Rate of patients with under-dosage of vancomycin at day 2 of treatment
time frame: day 2

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pharmacokinetics of Vancomycin in ICU Patients
Principal investigator Jean-Christophe RICHARD, Prof
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.