Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With CPB
Completed
- Conditions
- Surgical Site Infection
- Registration Number
- NCT03141450
- Lead Sponsor
- Mahidol University
- Brief Summary
Surgical site infection (SSI) is a serious operative complication that may be associated with any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery with cardiopulmonary bypass including its correlation with the incidence of postoperative SSI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- age < 7 years old
- undergoing elective cardiac surgery with cardiopulmonary bypass
- receive cefazolin as prophylactic antibiotic
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Exclusion Criteria
- Known or family history of penicillin or cephalosporins allergy
- Coexisting liver or renal disease
- Previous infection or received any antibiotics within 4 weeks
- Previous surgery with median sternotomy
- Predicted cardiopulmonary bypass time of less than 30 minutes or more than 150 minutes
- Severe hemodynamic instability during the operation, requiring mechanical circulatory support
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method plasma concentration of cefazolin in pediatric cardiopulmonary bypass 12 hours plasma concentration of cefazolin
- Secondary Outcome Measures
Name Time Method incidence of surgical site infection after elective pediatric cardiac surgery 30 days surgical site infection
Trial Locations
- Locations (1)
Faculty of Medicine, Siriraj Hospital, Mahidol University
🇹ðŸ‡Bangkok, Thailand