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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


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.


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


Inclusion Criteria:

- Scheduled to undergo cardiac surgery with cardiopulmonary bypass and modified


- 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

Page last updated: August 23, 2015

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