Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00426894
First received: January 24, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 24, 2007
January 24, 2007
January 2007
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Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery
Longitudinal Microbial Surveillance in Children Hospitalized for Cardiac Surgery Before the Operation and During Hospitalization

the purpose of this study is to determine whether children who are hospitalised waiting for cardiac surgery for several days in pediatric or pediatric surgery department acquire resistant microbial flora, thus necessitating broad spectrum antibiotics for perioperative prophylaxis.

Background

Guidelines for antimicrobial prophylaxis for cardiac surgery advise using first generation cephalosporin for those children coming from home. Large number of children that pass cardiac surgery in Hadassah University Hospital, Jerusalem, are hospitalized for several days before the operation in Pediatric Surgery department due to administrative reasons. These children receive broad spectrum antibiotics, vancomycin and ceftazidime, as a peri-operative prophylaxis, in order to prevent infection with hospital acquired flora with which they could become colonized with during this period. This policy causes exposure to broad spectrum antibiotics from the beginning in these children, and also providing an antimicrobial pressure in the intensive care unit, influencing the development of resistant flora.

There is no documentation that these children acquire resistant flora during there hospitalization in the pre-operative period. We suggest checking microbial flora in those children hospitalized for cardiac surgery, in order to determine the need for broad spectrum antimicrobial prophylaxis.

Goals

To check microbial flora in children hospitalized for cardiac surgery on different time points: on admission and during hospitalization in Pediatric Surgery Department, on admission to PICU (immediately after operation),after 3 - 5 days,when drains are extracted.

To document if there is a change in resistance pattern of microbial pathogens during these periods

To determine the optimal regimen for antimicrobial prophylaxis for those children who need to be hospitalized in this department before the operation

Methods

Surveillance cultures would be taken from children who are hospitalized for cardiac surgery on several time points:

  1. on admission to Pediatric Surgery or other department pre-operatively
  2. once weekly afterwards, if they continue to be hospitalized without surgery
  3. on admission to PICU after surgery
  4. during their subsequent hospitalization in PICU after 3 - 5 days
  5. on the day of drains extraction

These cultures will include the cultures of nostrils, throat,axillas, perineum and rectum and post operative wound.

Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Cardiac Surgery
  • Perioperative Prophylaxis
Procedure: samples from nostrils, mouth, axillas, perianal area and postoperative wound
Not Provided
Bratzler DW, Houck PM; Surgical Infection Prevention Guideline Writers Workgroup. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Am J Surg. 2005 Apr;189(4):395-404. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
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Inclusion Criteria:

  • All children and infants who are hospitalized in general pediatrics or pediatric surgery department before they undergo cardiac surgery
Both
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No
Contact: Dina Averbuch, MD 972-50-7874940 dina8282@walla.co.il
Contact: Hadas Lemberg, PhD 972 2 6777572 lhadas@hadassah.org.il
Israel
 
NCT00426894
yael01-HMO-CTIL
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Hadassah Medical Organization
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Principal Investigator: Dina Averbuch, MD Hadassah University Hospital, Jerusalem, Israel
Hadassah Medical Organization
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP