The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. Participation will be complete once the cardiac surgery has been finished.

Official Title
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The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery

Conditions
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Infection

Intervention / Treatment
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* Other: Vancomycin concentrations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vancomycin concentrations<br>Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. | Other: Vancomycin concentrations<br>* Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.<br>* Other names: serum concentrations of vancomycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating Vancomycin Concentration | Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery. | Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pump, heart lung machine, cardiac surgery, cardiopulmonary bypass, circulation