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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No