Outcomes Following Medical or Surgical Management of Endocarditis

Endocarditis Clinical Trial

Official title:

A Review of Outcomes Following Medical or Surgical Management of Endocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166023
• Other study ID #: 0549-2005
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 25, 2013
• Start date: August 2005
• Est. completion date: December 2006

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Endocarditis

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States,