Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426894
Recruitment Status : Unknown
Verified January 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 25, 2007
Last Update Posted : January 25, 2007
Information provided by:
Hadassah Medical Organization

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Perioperative Prophylaxis Procedure: samples from nostrils, mouth, axillas, perianal area and postoperative wound Not Applicable

Detailed Description:


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.


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


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.

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Longitudinal Microbial Surveillance in Children Hospitalized for Cardiac Surgery Before the Operation and During Hospitalization
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All children and infants who are hospitalized in general pediatrics or pediatric surgery department before they undergo cardiac surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426894

Contact: Dina Averbuch, MD 972-50-7874940
Contact: Hadas Lemberg, PhD 972 2 6777572

Hadassah University Hospital Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Diana Averbuch, MD         
Sub-Investigator: Shmuel Benenson, MD         
Sub-Investigator: Ido Yatsiv, MD         
Sub-Investigator: Eli Milgalter, MD         
Sub-Investigator: Matan J Cohen, MD MPh         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Dina Averbuch, MD Hadassah University Hospital, Jerusalem, Israel

Publications: Identifier: NCT00426894     History of Changes
Other Study ID Numbers: yael01-HMO-CTIL
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: January 25, 2007
Last Verified: January 2007

Keywords provided by Hadassah Medical Organization:
surveillance cultures
cardiac surgery
perioperative prophylaxis