Pharmacokinetics of Vancomycin in ICU Patients (PK-VANCO-ICU)
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|ClinicalTrials.gov Identifier: NCT02844192|
Recruitment Status : Unknown
Verified July 2016 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
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.
|Condition or disease|
|Suspected Infection With Vancomycin Susceptible Bacterial Strains|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Pharmacokinetics of Vancomycin in ICU Patients|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||August 2016|
- 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
- Rate of patients with under-dosage of vancomycin at day 2 of treatment [ Time Frame: day 2 ]under-dosage of vancomycin is defined by a vancomycin serum concentration below 15 mg/l on day 2 of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844192
|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, 69004|
|Principal Investigator:||Jean-Christophe RICHARD, Prof||Hospices Civils de Lyon|