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

PHASE4CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Congenital Heart DiseasesAortic Valve Disorder
Interventions
DRUG

Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride

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.

DRUG

Cefazolin 30 mg/kg body weight

"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."

Trial Locations (1)

94304

Lucile Packard Children's Hospital at Stanford, Palo Alto

All Listed Sponsors
lead

Stanford University

OTHER

NCT01619982 - Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients | Biotech Hunter | Biotech Hunter