Pharmacokinetics of Vancomycin in ICU Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02844192

Acronym

PK-VANCO-ICU

Enrollment

Registered

2016-07-26

Start date

2015-10-31

Completion date

2016-08-31

Last updated

2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected Infection With Vancomycin Susceptible Bacterial Strains

Keywords

Vancomycin, under dosage, intensive care unit, pharmacokinetics

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results