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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03141450
Enrollment
18
Registered
2017-05-05
Start date
2016-05-31
Completion date
2018-01-31
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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.

Interventions

None listed

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
plasma concentration of cefazolin in pediatric cardiopulmonary bypass12 hoursplasma concentration of cefazolin

Secondary

MeasureTime frameDescription
incidence of surgical site infection after elective pediatric cardiac surgery30 dayssurgical site infection

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026