Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 5/18/2018 |
| Start Date: | February 2012 |
| End Date: | December 2014 |
Effect of Pre-operative Prophylaxis With Vancomycin on Rate of Cefazolin Non-susceptible Gram Positive Surgical Site Infections in Cardiovascular Surgery Patients
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.
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.
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
(methicillin resistant Staphylococcus epidermidis, 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.
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
(methicillin resistant Staphylococcus epidermidis, 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.
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
We found this trial at
1
site
Click here to add this to my saved trials
