NCT00281281

Brief Summary

  1. 1.Vancomycin is a drug that requires precise dosing and close monitoring to avoid drug toxicity.
  2. 2.There is limited data on the change of vancomycin pharmacokinetics in patients who need extracorporeal membrane oxygenation (ECMO).
  3. 3.This control trial is to understand:
  4. 4.whether the pharmacokinetics of vancomycin is influenced by the use ECMO
  5. 5.design the most appropriate dose of vancomycin in adult patients using ECMO.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

First QC Date

January 22, 2006

Last Update Submit

December 4, 2012

Conditions

Extracorporeal Membrane Oxygenation

Keywords

Extracorporeal Membrane Oxygenationvancomycin

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic parameters

Interventions

vancomycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 y/o
  • receiving ECMO for study group
  • without ECMO for control group (sex, age, creatinine clearance match with study group)

You may not qualify if:

  • severe burn (\>30-40% BSA)
  • receiving continuous renal replacement therapy or hemodialysis concurrently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

Location

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Fe-Lin L Wu, MSCP, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2006

First Posted

January 24, 2006

Study Start

December 1, 2005

Study Completion

April 1, 2007

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

TW(1)