Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
Late Effects of Surgery, Staphylococcus Aureus, Surgical Site Infection
About this trial
This is an interventional prevention trial for Late Effects of Surgery focused on measuring Daptomycin, Antibiotic Prophylaxis, Pharmacokinetics, Surgical Wound Infection, Staphylococcus aureus, Cardiopulmonary Bypass Surgery
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients, awaiting scheduled elective coronary artery bypass graft (CABG) surgery without valve replacement surgery
- Age > 18 years and < 75 years
- BMI between 18.5 and 35.0 kg/meters-squared
- Crcl > 50 ml/minute calculated based on Cockcroft Gault equation
- No known active or suspected infection(s)
- Ability to complete the informed consent process
- Negative pregnancy test (for women of childbearing age)
Exclusion Criteria:
- History of allergic reaction to daptomycin or components of daptomycin
- Receipt of daptomycin within 7 days prior to the surgery
- Elevated CPK levels (defined as > 3 times the upper limits of known normal)
- History of myopathy or complaints consistent with myopathy
- Current or planned use of mycophenolate mofetil, mycophenolic acid, or tobramycin during the subjects' current hospitalization (all of which are known to interact with daptomycin)
- Inability to complete the informed consent process because of problems with mental capacity
- Pregnancy and/or breast feeding
Sites / Locations
- Harbor-UCLA Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Cases
Controls
The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.