Outcomes Following Medical or Surgical Management of Endocarditis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Kogon, Emory University
ClinicalTrials.gov Identifier:
NCT00166023
First received: September 12, 2005
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

Infective endocarditis is a rare disease, and while there have been several large reviews of the incidence of endocarditis in the pediatric patient population, relatively little has been published regarding the short and medium-term outcomes following medical and surgical therapy for this disease. The goal is to compare the outcome for children treated for endocarditis with either medical management or surgery by looking at the success of these two treatment strategies. Another goal is to attempt to identify risk factors for medical management that might identify patients who would be better served by early surgery.


Condition
Endocarditis

Study Type: Observational
Official Title: A Review of Outcomes Following Medical or Surgical Management of Endocarditis

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 100
Study Start Date: August 2005
Estimated Study Completion Date: December 2006
Detailed Description:

After identification of qualified subjects, the families of surviving patients will be mailed a package containing a cover letter explaining the study, a consent form, an assent form if applicable, a questionnaire (designed to evaluate longer-term outcome measures including the occurrence of recurrent endocarditis, late surgical intervention or the need for re-operations) and a self addressed stamped envelope to be used to return the consents and the questionnaire. The data will then be entered into a database and analyzed.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients discharged from Children's Healthcare of Atlanta at Egleston with a discharge diagnosis of endocarditis or those who underwent surgery with a preoperative diagnosis of endocarditis.
  • Admitted to the hospital between January 1, 1984 - December 31, 2004, inclusive.
  • Signed informed consent.

Exclusion Criteria:

  • Patients who do not have documented endocarditis based upon microbiology and echocardiography criteria.
  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: NCT00166023

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

No publications provided

Responsible Party: Brian Kogon, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00166023     History of Changes
Other Study ID Numbers: 0549-2005
Study First Received: September 12, 2005
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pediatric
cardiology

Additional relevant MeSH terms:
Endocarditis
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014