Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With CPB

Mahidol University18 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Surgical Site Infection

Eligibility

Sex: ALLMax age: 7 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age \< 7 years old 2. undergoing elective cardiac surgery with cardiopulmonary bypass 3. receive cefazolin as prophylactic antibiotic Exclusion Criteria: 1. Known or family history of penicillin or cephalosporins allergy 2. Coexisting liver or renal disease 3. Previous infection or received any antibiotics within 4 weeks 4. Previous surgery with median sternotomy 5. Predicted cardiopulmonary bypass time of less than 30 minutes or more than 150 minutes 6. Severe hemodynamic instability during the operation, requiring mechanical circulatory support

Locations (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Thailand

Outcomes

Primary Outcomes

plasma concentration of cefazolin in pediatric cardiopulmonary bypass

plasma concentration of cefazolin

Time frame: 12 hours

Secondary Outcomes

incidence of surgical site infection after elective pediatric cardiac surgery

surgical site infection

Time frame: 30 days

Data from ClinicalTrials.gov

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