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OpenTrials
Completed

NCT Number: NCT00281281

Pharmacokinetics 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.

Completed

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Key information

Conditions

Extracorporeal Membrane Oxygenation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, 10051, Taiwan

About this study

  • Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity.
  • 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).
  • There is limited data on the change of vancomycin pharmacokinetics in these patients.
  • This is a control trial using ICU patients who need vancomycin but not ECMO as a control to understand:
  • whether the pharmacokinetics of vancomycin is influenced by the use ECMO
  • design the most appropriate dose of vancomycin in adult patients using ECMO.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

Primary outcomes

  1. pharmacokinetic parameters

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Pharmacokinetics and Posology of Vancomycin in Adults Receiving ECMO

Important dates

Study start
2005
Study completion
2007
First posted
Jan 24, 2006
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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