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Pharmacokinetics of Vancomycin in Adults Receiving ECMO

Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Extracorporeal Membrane Oxygenation

Intervention: vancomycin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Fe-Lin L Wu, MSCP, PhD, Principal Investigator, Affiliation: National Taiwan University

Summary

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.

Clinical Details

Official title: Pharmacokinetics and Posology of Vancomycin in Adults Receiving ECMO

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pharmacokinetic parameters

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

National Taiwan University Hospital, Taipei 10051, Taiwan
Additional Information

Starting date: December 2005
Last updated: December 4, 2012

Page last updated: August 23, 2015

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