Cardiac Implantable Electronic Device Infections
Conditions
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
Interventions
OTHERprocalcitonin blood test
blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
• device associated infections
Exclusion criteria
* malignancy * cytostatic or immunomodulating therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic value of PCT | 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 |
Outcome results
None listed