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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141450
• Other study ID #: 449/2559
• Status: Completed
• Start date: May 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentration of cefazolin in pediatric cardiopulmonary bypass	plasma concentration of cefazolin	12 hours
Secondary	incidence of surgical site infection after elective pediatric cardiac surgery	surgical site infection	30 days