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Outcomes Following Medical or Surgical Management of Endocarditis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00166023
First Posted: September 14, 2005
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Kogon, Emory University
  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 Brian Kogon, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Brian Kogon, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00166023     History of Changes
Other Study ID Numbers: 0549-2005
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: November 26, 2013
Last Verified: November 2013

Keywords provided by Brian Kogon, Emory University:
pediatric
cardiology

Additional relevant MeSH terms:
Endocarditis
Heart Diseases
Cardiovascular Diseases