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.

Study Overview

• Status: Completed
• Conditions: Extracorporeal Membrane Oxygenation
• Intervention / Treatment: Drug: vancomycin

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
• Enrollment (Anticipated): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10051
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pharmacokinetic parameters

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Fe-Lin L Wu, MSCP, PhD, National Taiwan University

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Study Completion: April 1, 2007

Study Registration Dates

• First Submitted: January 22, 2006
• First Submitted That Met QC Criteria: January 23, 2006
• First Posted (Estimate): January 24, 2006

Study Record Updates

• Last Update Posted (Estimate): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: vancomycin; Extracorporeal Membrane Oxygenation
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 9461701147