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

M

Mahidol University

Status

Completed

Conditions

Surgical Site Infection

Study type

Observational

Funder types

Other

Identifiers

NCT03141450
449/2559

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

Under 7 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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