Infection
Conditions
Keywords
heart lung machine, blood pump, cardiac surgery, cardiopulmonary bypass, circulation
Brief 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.
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. 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.
Interventions
OTHERVancomycin concentrations
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.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circulating Vancomycin Concentration | 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) | Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Vancomycin Concentrations |
|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 16.1 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Circulating Vancomycin Concentration
Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vancomycin Concentrations | Circulating Vancomycin Concentration | 15.6 µg/mL | Standard Deviation 4.4 |
p-value: <0.000195% CI: [-0.098, -0.039]Mixed Models Analysis