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Infection in DiGeorge Following CHD Surgery

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ClinicalTrials.gov Identifier: NCT00278005
Recruitment Status : Terminated (completed)
First Posted : January 18, 2006
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta

Tracking Information
First Submitted Date January 13, 2006
First Posted Date January 18, 2006
Last Update Posted Date March 16, 2012
Study Start Date January 1998
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Infection in DiGeorge Following CHD Surgery
Official Title Incidence of Infection in the Patient With DiGeorge Syndrome Following Surgery for Congenital Heart Disease
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 Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population DiGeorge Syndrome Cardiac Surgery
Condition
  • DiGeorge Syndrome
  • Congenital Heart Defects
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January¬†13,¬†2006)
400
Original Enrollment Same as current
Actual Study Completion Date March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children's Healthcare of Atlanta patients, Egleston DiGeorge Syndrome Cardiac Surgery 200 medical charts between Jan 1, 1998 and April 31, 2005 with cardiac surgery and DiGeorge Syndrome 200 medical charts between Jan 1, 1998 and April 31,2005 with cardiac surgery and no DiGeorge Syndrome

Exclusion Criteria:

  • Those who do not meet inclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00278005
Other Study ID Numbers 05-134
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Healthcare of Atlanta
Study Sponsor Children's Healthcare of Atlanta
Collaborators Not Provided
Investigators
Principal Investigator: Kevin O Maher, MD Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
PRS Account Children's Healthcare of Atlanta
Verification Date March 2008