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Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
Not Recruiting
Trial ID: NCT01619982
Purpose
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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Official Title
Effect of Pre-operative Prophylaxis With Vancomycin on Rate of Cefazolin Non-susceptible Gram Positive Surgical Site Infections in Cardiovascular Surgery Patients
Stanford Investigator(s)
Chandra Ramamoorthy
Professor of Anesthesiology, Perioperative and Pain Medicine (Pediatric), Emerita
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
Intervention(s):
drug: Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride
drug: Cefazolin 30 mg/kg body weight
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kathleen Gutierrez, MD
650-736-7642