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

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congenital Heart Diseases; Aortic Valve Disorder

Intervention: Cefazolin pre-operative prophylaxis (Drug); Vancomycin hydrochloride (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Kathleen Gutierrez, MD, Principal Investigator, Affiliation: Stanford University


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.

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Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Effectiveness of pre-operative vancomycin in prevention of cefazolin resistant surgical site infections in children undergoing cardiovascular surgery involving cardiopulmonary bypass, compared to historical controls receiving only cefazolin

Secondary outcome:

Cefazolin pharmacokinetics (Plasma concentration vs time curve) in children during cardiopulmonary bypass (CPB).

Vancomycin pharmacokinetics (plasma concentration vs time curve) in children on cardiopulmonary bypass (CPB)

Evaluation of adverse events associated with peri-operative vancomycin prophylaxis

Detailed description: With 100% compliance with the surgical infection prevention (SIP) bundle, the risk of surgical site infections (SSIs) has decreased considerably, but is still greater than the baseline rate at the best comparison hospital (2. 5%). Recent analysis of SSI's in cardiovascular surgery patients identified more than half being caused by cefazolin resistant gram positive bacteria (methicillin resistant coagulase negative staphylococci- MRSE, or methicillin resistant Staphylococcus aureus- MRSA). Cefazolin is routinely given pre-operatively as surgical prophylaxis in patients undergoing cardiovascular surgery. Vancomycin is not routinely recommended for prophylaxis due to concerns of developing vancomycin resistance, however patients with MRSE and MRSA SSIs end up needing additional surgery to remove or replace infected hardware or grafts and/or additional weeks to months of intravenous vancomycin therapy. This results in significant morbidity to the children and cost to the institution. Several published guidelines suggest the use of pre-operative prophylaxis with vancomycin (alone or in conjunction with cefazolin) in instances where patients may be at higher risk for infection with MRSE or MRSA. The purpose of this study is to determine whether the addition of vancomycin to standard pre-operative prophylaxis with cefazolin in selected high risk subjects along with the full SIP bundle will decrease the incidence of cefazolin-resistant SSI's.


Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.


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

Locations and Contacts

Lucile Packard Children's Hospital at Stanford, Palo Alto, California 94304, United States
Additional Information

Related publications:

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80.

Starting date: February 2012
Last updated: September 29, 2014

Page last updated: August 23, 2015

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