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Pharmacokinetics of Vancomycin in Adults Receiving ECMO

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ClinicalTrials.gov Identifier: NCT00281281
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : December 6, 2012
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
  1. Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity.
  2. There is limited data on the change of vancomycin pharmacokinetics in patients who need extracorporeal membrane oxygenation (ECMO).
  3. This control trial is to understand:

    1. whether the pharmacokinetics of vancomycin is influenced by the use ECMO
    2. design the most appropriate dose of vancomycin in adult patients using ECMO.

Condition or disease Intervention/treatment Phase
Extracorporeal Membrane Oxygenation Drug: vancomycin Phase 4

Detailed Description:
  1. Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity.
  2. Oftentimes it is used in intensive care units (ICU) for patients who need a life-saving machine for heart and lung failure called extracorporeal membrane oxygenation (ECMO).
  3. There is limited data on the change of vancomycin pharmacokinetics in these patients.
  4. This is a control trial using ICU patients who need vancomycin but not ECMO as a control to understand:

    1. whether the pharmacokinetics of vancomycin is influenced by the use ECMO
    2. design the most appropriate dose of vancomycin in adult patients using ECMO.
  5. After the 4th dose of vancomycin, blood was drawn at appropriate time spots (1 mL each) to determine the time concentration curve and to calculate the pharmacokinetic parameters for 2 groups of patients to determine if there is any difference.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Posology of Vancomycin in Adults Receiving ECMO
Study Start Date : December 2005
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. pharmacokinetic parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 y/o
  • receiving ECMO for study group
  • without ECMO for control group (sex, age, creatinine clearance match with study group)

Exclusion Criteria:

  • severe burn (>30-40% BSA)
  • receiving continuous renal replacement therapy or hemodialysis concurrently

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): NCT00281281


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10051
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Fe-Lin L Wu, MSCP, PhD National Taiwan University

ClinicalTrials.gov Identifier: NCT00281281     History of Changes
Other Study ID Numbers: 9461701147
First Posted: January 24, 2006    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by National Taiwan University Hospital:
Extracorporeal Membrane Oxygenation
vancomycin

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents