Pharmacokinetics of Vancomycin in ICU Patients

• Conditions: Suspected Infection With Vancomycin Susceptible Bacterial Strains

• Registration Number: NCT02844192
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-21
• Last Update Submitted: 2016-07-21
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration	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 Outcome Measures

Name	Time	Method
Rate of patients with under-dosage of vancomycin at day 2 of treatment	day 2	under-dosage of vancomycin is defined by a vancomycin serum concentration below 15 mg/l on day 2 of treatment.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire,103 Grande Rue de la Croix-Rousse; 🇫🇷 Lyon, France