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Outcomes Following Medical or Surgical Management of Endocarditis

Primary Purpose

Endocarditis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Endocarditis focused on measuring pediatric, cardiology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Healthcare of Atlanta

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
November 25, 2013
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00166023
Brief Title
Outcomes Following Medical or Surgical Management of Endocarditis
Official Title
A Review of Outcomes Following Medical or Surgical Management of Endocarditis
Study Type
Observational

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis
Keywords
pediatric, cardiology

7. Study Design

Enrollment
100 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Kirshbom, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Outcomes Following Medical or Surgical Management of Endocarditis

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