Endocarditis Registry of the University Hospital of Cologne (ER-UHC)

Infective Endocarditis Clinical Trial

Official title:

Endocarditis Registry of the University Hospital of Cologne (ER-UHC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02388893
• Other study ID #: 14-221
• Secondary ID: 14-221
• Status: Recruiting
• Start date: January 2013
• Est. completion date: December 2022

Study information

• Verified date: October 2018
• Source: University of Cologne
• Contact: Guido Michels, Prof. Dr.
• Phone: ++49-221-478-32401
• Email: guido.michels[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry is a prospective, national registry of patients with IE. From January 2013 data from endocarditis board were prospectively recorded using standard definitions during the hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.

Description:

The primary endpoint will be the 1 year all-cause mortality after treatment begins of IE. We will use 1 year all-cause mortality as the primary endpoint because it has been demonstrated that a period of at least 6 months is necessary to offset the early postoperative mortality related to valve surgery. We also looked at all-cause in-hospital mortality as a secondary endpoint.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• All patients with patients with definitive infective endocarditis

Exclusion Criteria:

• childs

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Locations

Country	Name	City	State
Germany	Heart Center of the University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	1-year all-cause mortality	1 year
Secondary	Inhospital all-cause mortality		1 month