Validation of Procalcitonin as a Biomarker Diagnosing CDI

Deutsches Herzzentrum Muenchen200 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Cardiac Implantable Electronic Device Infections

Interventions

procalcitonin blood testOTHER

blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: • device associated infections Exclusion Criteria: * malignancy * cytostatic or immunomodulating therapy

Outcomes

Primary Outcomes

diagnostic value of PCT

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

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)

Data from ClinicalTrials.gov

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