Pharmacokinetics of Vancomycin in ICU Patients

NCT ID: NCT02844192

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Suspected Infection With Vancomycin Susceptible Bacterial Strains

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe RICHARD, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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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

Site Status

Countries

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France

Other Identifiers

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69HCL16_0452

Identifier Type: -

Identifier Source: org_study_id

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