Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients

Completed · Phase 4

Conditions studied: Congenital Heart Diseases, Aortic Valve Disorder

In brief

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. \--------------------------------------------------------------------------------

Key facts

Study ID

NCT01619982

Run by

Stanford University

People needed

32

Starts

2012-02-01

Expected to finish

2014-12-01

Last updated by the study team

2018-05-16

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patients with a positive MRSA screen or a history of MRSA infections who are undergoing any cardiac surgery

You may not qualify if…

• Patients who have known hypersensitivity to vancomycin or cephalosporins
• Patients with renal insufficiency
• Patients who have received vancomycin or cephalosporins 48 hours prior to the day of surgery
• Patients whose surgery is due to an infection-related diagnosis such as endocarditis
• Patients whose parents do not wish to have them receive vancomycin prophylaxis
• Neonates born at less than 38 weeks gestational age

Where it is running

• Lucile Packard Children's Hospital at Stanford — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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