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

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 Overview

• Status: Completed
• Conditions: Surgical Site Infection

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine, Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients whose age less than 7 years old, undergo elective cardiac surgery with cardiopulmonary bypass.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma concentration of cefazolin in pediatric cardiopulmonary bypass	plasma concentration of cefazolin	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of surgical site infection after elective pediatric cardiac surgery	surgical site infection	30 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Saowaphak Lapmahapaisan, MD, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection
• Other Study ID Numbers: 449/2559

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No