Pharmacokinetics of Vancomycin in ICU Patients (PK-VANCO-ICU)

July 21, 2016 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hospices Civils de Lyon - Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire,103 Grande Rue de la Croix-Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-Christophe RICHARD, Prof, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ANTICIPATED)

August 1, 2016

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (ESTIMATE)

July 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0452

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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