Pro-Calcitonin Levels Following Pediatric Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Kevin O. Maher, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00284570
First received: January 30, 2006
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.

Hypothesis

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
Congenital Heart Disease
Sepsis
Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ProCalcitonin in the Pediatric Surgical Patient, Evaluation of a New Marker of Infection

Resource links provided by NLM:


Further study details as provided by Emory University:

Biospecimen Retention:   Samples With DNA

Blood samples are collected in order to get the procalcitonin level.


Enrollment: 49
Study Start Date: January 2006
Study Completion Date: March 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284570

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Kevin Maher, MD Emory University
  More Information

Publications:
Responsible Party: Kevin O. Maher, MD, Associate Prefessor of Pediatrics, Emory University
ClinicalTrials.gov Identifier: NCT00284570     History of Changes
Other Study ID Numbers: IRB00002022
Study First Received: January 30, 2006
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
pediatrics
congenital heart disease
cardiac
cardiopulmonary bypass
infection
sepsis
postoperative
marker for infection
inflammation
cardiac surgery

Additional relevant MeSH terms:
Heart Diseases
Sepsis
Heart Defects, Congenital
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014