(DIRT II): Validation of Procalcitonin as a Biomarker Diagnosing CDI
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| pocket infection 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
blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
|
| CIED systemic infection 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
blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
|
| Lead-associated infective endocarditis Patients with infective endocarditis, diagnosed according to modified Duke criteria |
Other: procalcitonin blood test
blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
|
| control group 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
blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
• device associated infections
Exclusion Criteria:
-
malignancy
-
cytostatic or immunomodulating therapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Deutsches Herzzentrum Muenchen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GER-EP-023