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

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ClinicalTrials.gov Identifier: NCT02388893
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Guido Michels, University of Cologne

Brief 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.

Condition or disease
Infective Endocarditis

Detailed 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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Endocarditis Registry of the University Hospital of Cologne (ER-UHC)
Actual Study Start Date : January 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 1 year ]
    1-year all-cause mortality


Secondary Outcome Measures :
  1. Inhospital all-cause mortality [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with definitive IE
Criteria

Inclusion Criteria:

  • All patients with patients with definitive infective endocarditis

Exclusion Criteria:

  • childs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388893


Contacts
Contact: Guido Michels, Prof. Dr. ++49-221-478-32401 guido.michels@uk-koeln.de
Contact: Norma Jung, Dr. ++49-221-478-0 norma.jung@uk-koeln.de

Locations
Germany
Heart Center of the University of Cologne Recruiting
Cologne, Germany, 50937
Contact: Guido Michels, Prof. Dr.    ++49-221-478-32401    guido.michels@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Guido Michels, Prof. Dr. Heart Center, University of Cologne, Germany

Responsible Party: Guido Michels, Dr. Guido Michels, University of Cologne
ClinicalTrials.gov Identifier: NCT02388893     History of Changes
Other Study ID Numbers: 14-221
14-221 ( Other Identifier: Ethics committee of the University of Cologne )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection