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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin concentrations | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin concentrations | Other | 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ettore Crimi, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vancomycin Concentrations | Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vancomycin Concentrations | Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Circulating Vancomycin Concentration | Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery. | Posted | Mean | Standard Deviation | µg/mL | 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) |
|
12 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vancomycin Concentrations | Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ettore Crimi | University of Florida | 617-697-2861 | ettorecrimi@gmail.com |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| 0 |
| 25 |
| 0 |
| 25 |
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