Outcomes Following Medical or Surgical Management of Endocarditis

Completed

• Conditions: Endocarditis

• Registration Number: NCT00166023
• Lead Sponsor: Emory University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Study Completion: 2006-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States