Education and Training
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of vancomycin and cefazolin pharmacokinetics in children undergoing cardiopulmonary bypass (CPB) 3) to assess the barriers to vancomycin dosing peri-operatively 4) to assess side effects and risks associated with peri-operative vancomycin administration. This will allow us to improve patient care by better understanding the benefits or the risks of peri-operative vancomycin administration and potentially decrease cefazolin-resistant surgical site infections.
In addition, this study gives us the opportunity to evaluate cefazolin and vancomycin pharmacokinetics (pK) on children on CPB.
The investigators will take blood samples from 20 patients. In 10 patients the investigators will do Cefazolin pK analysis and in the other 10 the investigators will do pK Vancomycin analysis. For the remainder of 292 patients, only prospective chart review will be done to determine the incidence of SSIs.
This data will be compared with 936 controls who received only Cefazolin pre-operatively as prophylaxis for SSI's.
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Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride
- drug: Cefazolin 30 mg/kg body weight
Eligibility
Inclusion Criteria:
1. Patient less than or equal to 1 year of age who is undergoing cardiovascular surgery
requiring CPB or patient under 18 years of age undergoing procedures involving aortic
valve or aorta
2. Patients with a positive MRSA screen or a history of MRSA infections who are
undergoing any cardiac surgery
Exclusion Criteria:
1. Patients who have known hypersensitivity to vancomycin or cephalosporins
2. Patients with renal insufficiency
3. Patients who have received vancomycin or cephalosporins 48 hours prior to the day of
surgery
4. Patients whose surgery is due to an infection-related diagnosis such as endocarditis
5. Patients whose parents do not wish to have them receive vancomycin prophylaxis
6. Neonates born at less than 38 weeks gestational age
Ages Eligible for Study
N/A - 18 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kathleen Gutierrez, MD
650-736-7642
Not Recruiting