Trial ID or NCT#

NCT01619982

Status

NOT RECRUITING

Purpose

The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible SSI's, in high risk population 2) to develop better understanding of vancomycin and cefazolin pharmacokinetics in children undergoing cardiopulmonary bypass 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 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 SSI's. This data will be compared with 936 controls who received only Cefazolin pre-operatively as prophylaxis for SSI's.

Official Title

Effect of Pre-operative Prophylaxis With Vancomycin on Rate of Cefazolin Non-susceptible Gram Positive Surgical Site Infections in Cardiovascular Surgery Patients

Eligibility Criteria

Ages Eligible for Study: Younger than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Kathleen Gutierrez
Chandra Ramamoorthy
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine (Pediatric) at the Stanford University Medical Center
Yvonne Maldonado
Senior Associate Dean, Faculty Development and Diversity and Professor of Pediatrics (Infectious Diseases)

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CONTACT

Kathleen Gutierrez, MD
(650) 736-7642