Pro-Calcitonin Levels Following Pediatric Cardiac Surgery

NCT00284570 | Completed

• 1 other identifier: IRB00002022
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Congenital Heart Disease; Sepsis; Infection

Keywords

pediatrics; congenital heart disease; cardiac; cardiopulmonary bypass; infection; sepsis; postoperative; marker for infection; inflammation; cardiac surgery

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (6)

• Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.

  PMID: 12700374 BACKGROUND

• Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

  PMID: 11445675 BACKGROUND

• Hauser GJ, Chan MM, Casey WF, Midgley FM, Holbrook PR. Immune dysfunction in children after corrective surgery for congenital heart disease. Crit Care Med. 1991 Jul;19(7):874-81. doi: 10.1097/00003246-199107000-00009.

  PMID: 2055075 BACKGROUND

• Jarvis WR, Edwards JR, Culver DH, Hughes JM, Horan T, Emori TG, Banerjee S, Tolson J, Henderson T, Gaynes RP, et al. Nosocomial infection rates in adult and pediatric intensive care units in the United States. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):185S-191S. doi: 10.1016/0002-9343(91)90367-7.

  PMID: 1928163 BACKGROUND

• Mayhall CG. Diagnosis and management of infections of implantable devices used for prolonged venous access. Curr Clin Top Infect Dis. 1992;12:83-110. No abstract available.

  PMID: 1642805 BACKGROUND

• Galetto-Lacour A, Zamora SA, Gervaix A. Bedside procalcitonin and C-reactive protein tests in children with fever without localizing signs of infection seen in a referral center. Pediatrics. 2003 Nov;112(5):1054-60. doi: 10.1542/peds.112.5.1054.

  PMID: 14595045 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Heart Defects, Congenital; Sepsis; Infections; Inflammation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Maher, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prefessor of Pediatrics

Study Record Dates

• First Submitted: January 30, 2006
• First Posted: February 1, 2006
• Study Start: January 1, 2006
• Study Completion: March 1, 2007
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (1)