Validation of Procalcitonin as a Biomarker Diagnosing CDI

Study Overview
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Brief Summary
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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

Official Title
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A Prospective Case-control Validation of Procalcitonin as a Biomarker Diagnosing Pacemaker and Implantable Cardioverter Defibrillator Pocket Infection

Conditions
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Cardiac Implantable Electronic Device Infections

Intervention / Treatment
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* Other: procalcitonin blood test


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pocket infection<br>Patients with isolated pocket infection were diagnosed in the presence of local signs of inflammation (one or more of erythema, pain, warmth, swelling, induration, tenderness, or fluctuation), wound dehiscence, hardware protrusion or pus discharge at the pocket in the absence of systemic findings. | Other: procalcitonin blood test<br>* blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit<br>|
| CIED systemic infection<br>Patient s with a CIED systemic infection, diagnosed as the presence of pocket infection accompanied by bacteraemia or echocardiographic finding suggestive of infective endocarditis, but not fulfilling the Duke criteria. | Other: procalcitonin blood test<br>* blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit<br>|
| Lead-associated infective endocarditis<br>Patients with infective endocarditis, diagnosed according to modified Duke criteria | Other: procalcitonin blood test<br>* blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit<br>|
| control group<br>CIED Patients presenting for elective device exchange or planned lead revision between without local or systemic infections were selected as controls | Other: procalcitonin blood test<br>* blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) |