Clincosm LogoSign in Get a demo

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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT03141450
Collaborator
(none)
18
Enrollment
1
Location
20
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    18 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
    Actual Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Jan 1, 2018
    Actual Study Completion Date :
    Jan 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. plasma concentration of cefazolin in pediatric cardiopulmonary bypass [12 hours]

      plasma concentration of cefazolin

    Secondary Outcome Measures

    1. incidence of surgical site infection after elective pediatric cardiac surgery [30 days]

      surgical site infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Saowaphak Lapmahapaisan, MD, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saowaphak Lapmahapaisan, Asst. Prof., Mahidol University
    ClinicalTrials.gov Identifier:
    NCT03141450
    Other Study ID Numbers:
    • 449/2559
    First Posted:
    May 5, 2017
    Last Update Posted:
    Apr 6, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Surgical Wound Infection

    Study Results

    No Results Posted as of Apr 6, 2020