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

NCT03141450 | Completed

• 1 other identifier: 449/2559
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• plasma concentration of cefazolin in pediatric cardiopulmonary bypass

  plasma concentration of cefazolin

  12 hours

Secondary Outcomes (1)

• incidence of surgical site infection after elective pediatric cardiac surgery

  30 days

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• age \< 7 years old
• undergoing elective cardiac surgery with cardiopulmonary bypass
• receive cefazolin as prophylactic antibiotic

You may not qualify if:

• Known or family history of penicillin or cephalosporins allergy
• Coexisting liver or renal disease
• Previous infection or received any antibiotics within 4 weeks
• Previous surgery with median sternotomy
• Predicted cardiopulmonary bypass time of less than 30 minutes or more than 150 minutes
• Severe hemodynamic instability during the operation, requiring mechanical circulatory support

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saowaphak Lapmahapaisan, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: May 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

TH (1)