Outcomes Following Medical or Surgical Management of Endocarditis

NCT ID: NCT00166023

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Endocarditis

Keywords

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pediatric cardiology

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Brian Kogon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Kirshbom, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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0549-2005

Identifier Type: -

Identifier Source: org_study_id