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Trial record 22 of 528 for:    VANCOMYCIN

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
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease
Suspected Infection With Vancomycin Susceptible Bacterial Strains

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
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
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jean-Christophe RICHARD, Prof Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02844192     History of Changes
Other Study ID Numbers: 69HCL16_0452
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
Vancomycin
under dosage
intensive care unit
pharmacokinetics
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents