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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

January 22, 2006
December 4, 2012
December 2005
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pharmacokinetic parameters
Same as current
Complete list of historical versions of study NCT00281281 on ClinicalTrials.gov Archive Site
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Pharmacokinetics of Vancomycin in Adults Receiving ECMO
Pharmacokinetics and Posology of Vancomycin in Adults Receiving ECMO
  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.
  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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Extracorporeal Membrane Oxygenation
Drug: vancomycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2007
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00281281
9461701147
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National Taiwan University Hospital
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Principal Investigator: Fe-Lin L Wu, MSCP, PhD National Taiwan University
National Taiwan University Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP