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

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Civil Hospices of Lyon

Status

Unknown

Conditions

Suspected Infection With Vancomycin Susceptible Bacterial Strains

Study type

Observational

Funder types

Other

Identifiers

NCT02844192
69HCL16_0452

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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