View Clinical Trial (Medical Research Study)
Effect of Pre-operative Prophylaxis With Vancomycin on Rate of Cefazolin Non-susceptible Gram Positive Surgical Site Infections in Cardiovascular Surgery Patients
| City: |
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Palo Alto |
| State: |
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California |
| Zip Code: |
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94304 |
| Conditions: |
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Congenital Heart Diseases - Aortic Valve Disorder |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01619982 |
| Primary Contact: |
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Principal Investigator
Kathleen Gutierrez, MD
Stanford University
Kathleen Gutierrez, MD
Phone: 650-736-7642
Email: mdkat@stanford.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Palo Alto, California 94304
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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