Role of New Diagnostic Tool in Device (ICD / PM) Associated Infections

Completed

• Conditions: Biomarkers in Device Associated Infections

• Registration Number: NCT01619267
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

Infections related to implantable pacemakers or cardioverters defibrillators are sometimes difficult to be diagnosed. Diificulties in the diagnosis include a low sensitivity of standard markers of inflammation such as C-reactive protein or white blood cell count and the diagnosis is mainly based on the clinical presentation. The observational DIRT-study evaluates if new biomarkers may be more suitable to support a diagnosis of device associated infections than the currently available ones.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• device associated infections

Exclusion Criteria

• malignancy
• cytostatic or immunomodulating therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
procalcitonine	no follow-up	procalcitonine is determined at inclusion and correlated to infectíon status

Trial Locations

Locations (4)

Krankenhaus Landshut-Achdorf; 🇩🇪 Landshut, Germany

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia

Deutsches Herzzentrum; 🇩🇪 München, Germany

Ospedale San Pietro FBF; 🇮🇹 Rome, Italy