Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
Condition: Congenital Heart Diseases; Aortic Valve Disorder
MeSH terms: Heart Diseases; Heart Defects, Congenital; Aortic Valve Disease
Intervention: Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride; Cefazolin 30 mg/kg body weight
Intervention description: Cefazolin 25 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery and Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion) For patients younger than 1 month of age, a one-time repeat dose of 15 mg/kg can be given intraoperatively 12 hours after the beginning of the first vancomycin dose if the procedure is > 12 hours in duration. For patients equal to or older than 1 month, a one-time repeat dose of 15 mg/kg (max 1.5 grams) will be given intra-operatively 8 hours after the beginning of the first vancomycin dose if the procedure is > 8 hours in duration.; Intervention: Drug: Cefazolin pre-operative prophylaxis
Other Names:
Cefazolin: Brand Names Ancef, Kefzol
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Intervention MeSH terms: Vancomycin; Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      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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Eligibility criteria:

        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