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Pro-Calcitonin Levels Following Pediatric Cardiac 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: NCT00284570
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : November 27, 2013
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Kevin O. Maher, MD, Emory University

Brief Summary:

First, we, the researchers, hope to find out the PCT response to heart surgery in children by taking blood before surgery and each day for four days after surgery. These blood draws will help us figure out the typical Procalcitonin (PCT) response, the normal increase in PCT after heart surgery, and when the PCT level returns to baseline.

Second, we, the researchers, hope to determine the accuracy of PCT as a marker of infection.


Our hypothesis is that Procalcitonin is superior to other currently used markers of infection and will prove to be a clinically useful tool for evaluation of infection in children following cardiac surgery.

Condition or disease
Congenital Heart Disease Sepsis Infection

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ProCalcitonin in the Pediatric Surgical Patient, Evaluation of a New Marker of Infection
Study Start Date : January 2006
Actual Study Completion Date : March 2007

Biospecimen Retention:   Samples With DNA
Blood samples are collected in order to get the procalcitonin level.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study patients will be recruited from Children's Healthcare of Atlanta at Egleston. The patients will be in the pre-operative clinic, Cardiac Intensive Care Unit or the Cardiac Stepdown Unit.

Inclusion Criteria:

  • Patients with congenital heart disease
  • Undergoing cardiopulmonary bypass and cardiac surgery
  • Newborn (full term) to up to 6 years of age

Exclusion Criteria:

  • Premature (less than 37 weeks)
  • 6 years of age or older
  • Intercurrent illness at time of surgery
  • Orthotopic organ transplant recipient
  • Pre-operative extra-corporeal support (ECMO)
  • Acquired heart disease

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): NCT00284570

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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
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Principal Investigator: Kevin Maher, MD Emory University
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Responsible Party: Kevin O. Maher, MD, Associate Prefessor of Pediatrics, Emory University Identifier: NCT00284570    
Other Study ID Numbers: IRB00002022
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by Kevin O. Maher, MD, Emory University:
congenital heart disease
cardiopulmonary bypass
marker for infection
cardiac surgery
Additional relevant MeSH terms:
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Communicable Diseases
Heart Diseases
Cardiovascular Diseases