The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacovigilance
Intervention: Vancomycin concentrations (Other)
Phase: Phase 0
Status: Completed
Sponsored by: University of Florida Official(s) and/or principal investigator(s): Ettore Crimi, MD, Principal Investigator, Affiliation: University of Florida
Summary
Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely
used antibiotic for surgery in patients with an allergy to penicillin. During cardiac
surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used
and can lower the level of the antibiotic. The purpose of this study is to quantify the
change in plasma vancomycin concentration associated with cardiopulmonary bypass and
modified ultrafiltration.
Clinical Details
Official title: The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
Study design: Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Circulating Vancomycin Concentration
Detailed description:
Subjects having cardiac surgery in which they will be on a heart-lung machine and will
receive the antibiotic vancomycin, will be able to participate.
During the surgery once receiving vancomycin, several samples of blood will be collected to
test the vancomycin levels. Participation will be complete once the cardiac surgery has
been finished.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Scheduled to undergo cardiac surgery with cardiopulmonary bypass and modified
ultrafiltration
- age greater than 18 years old
- penicillin allergy or in-hospital stay greater than 24 hours
- normal renal function
- normal liver function
- absence of clinical and laboratory signs of infection
Exclusion Criteria:
- vancomycin allergy
- pregnancy
- impaired renal function
- impaired liver function
- morbid obesity
- active infections
- Jehovah's Witness
Locations and Contacts
UF Health, Gainesville, Florida 32610, United States
Additional Information
Starting date: April 2014
Last updated: June 23, 2015
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