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Pharmacokinetics of Vancomycin in Adults Receiving ECMO

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00281281
First received: January 22, 2006
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose
  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 Intervention Phase
Extracorporeal Membrane Oxygenation
 Drug: vancomycin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Posology of Vancomycin in Adults Receiving ECMO

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • pharmacokinetic parameters

Estimated Enrollment: 24
Study Start Date: December 2005
Estimated Study Completion Date: April 2007
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00281281     History of Changes
Other Study ID Numbers: 9461701147
Study First Received: January 22, 2006
Last Updated: December 4, 2012
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013