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OpenTrials
Completed

NCT Number: NCT03141450

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

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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Key information

Conditions

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

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. plasma concentration of cefazolin in pediatric cardiopulmonary bypass

    Time frame: 12 hours

    plasma concentration of cefazolin

Secondary outcomes

  1. incidence of surgical site infection after elective pediatric cardiac surgery

    Time frame: 30 days

    surgical site infection

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 5, 2017
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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