Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00278005
Status:
TERMINATED
Last Update Posted:
2012-03-16
First Post:
2006-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infection in DiGeorge Following CHD Surgery
Sponsor:
Children's Healthcare of Atlanta
Organization:
Study Overview
Official Title:
Incidence of Infection in the Patient With DiGeorge Syndrome Following Surgery for Congenital Heart Disease
Status:
TERMINATED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We propose a retrospective review of patients with DiGeorge syndrome having undergone cardiac surgery to evaluate the incidence of blood stream and/or surgical site infection. The hypothesis is that we will find an increased number of infections for this sub-group. We will compare the incidence of infection to children of similar age and diagnosis to evaluate for variances in the incidence of infection.
Detailed Description:
DiGeorge syndrome is a common genetic disorder that frequently results in congenital heart defects such as truncus arteriousus, coarctation of the aorta, interrupted aortic arch, tetralogy of Fallot, pulmonary atresia with VSD, and several others. The defect is usually due to a deletion in the long arm of chromosome 22. Approximately 25% of patients with DiGeorge have a congenital heart defect. These patients also have varying degrees of thymic hypoplasia with associated T cell dysfunction. They are at increased risk of infections and can be at risk for opportunistic infections when the degree of T cell dysfunction is severe. Children undergoing cardiac surgery are at risk for infections in the post-operative period, prolonging hospital stay and increasing morbidity and mortality. The patient with DiGeorge syndrome may have higher rates of infection due to associated immune system dysfunction, however, this has not been previously reported from a large group of DiGeorge syndrome patients. Children's Healthcare of Atlanta follows over 200 patients with DiGeorge syndrome, with the majority having previously undergone cardiac surgery. This group of patients may benefit from more extensive antibiotic prophylaxis following surgery if they indeed have significantly higher rates of infection, but the true incidence needs to be determined.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: