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Pharmacokinetics of Vancomycin in Adults Receiving ECMO

NCT ID: NCT00281281

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extracorporeal Membrane Oxygenation

Keywords

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Extracorporeal Membrane Oxygenation vancomycin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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vancomycin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Fe-Lin L Wu, MSCP, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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9461701147

Identifier Type: -

Identifier Source: org_study_id