A Prospective Case-control Validation of Procalcitonin as a Biomarker Diagnosing Pacemaker and Implantable Cardioverter Defibrillator Pocket Infection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Implantable Electronic Device Infections
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 200
- Primary Endpoint
- diagnostic value of PCT
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity. The diagnosis of a local pocket infection is challenging and relies primarily on the clinical presentation. The prospective DIRT study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection.
The study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection
Investigators
Eligibility Criteria
Inclusion Criteria
- •device associated infections
Exclusion Criteria
- •malignancy
- •cytostatic or immunomodulating therapy
Outcomes
Primary Outcomes
diagnostic value of PCT
Time Frame: pre-intervention/procedure/surgery. i.e. at the time of CIED explantation. Measurement of PCT as an biomarker revealing the acute infection (like a sepsis marker)
diagnostic value of PCT in differentiating local pocket infection from infection-free controls and calculated the sensitivity and specificity of the pre-established cut-off value of 0.05 ng/ml