Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-05 @ 9:12 PM
Study NCT ID:
NCT02844192
Status:
UNKNOWN
Last Update Posted:
2016-07-26
First Post:
2016-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Vancomycin in ICU Patients
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Pharmacokinetics of Vancomycin in ICU Patients
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PK-VANCO-ICU
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: