Validation of Procalcitonin as a Biomarker Diagnosing CDI

Completed

• Conditions: Cardiac Implantable Electronic Device Infections
• Interventions: Other: procalcitonin blood test

• Registration Number: NCT05007158
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-31
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-16
• Primary Completion: 2021-10-10
• Study Completion: 2021-11-01
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• device associated infections

Exclusion Criteria

• malignancy
• cytostatic or immunomodulating therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lead-associated infective endocarditis	procalcitonin blood test	Patients with infective endocarditis, diagnosed according to modified Duke criteria
pocket infection	procalcitonin blood test	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.
control group	procalcitonin blood test	CIED Patients presenting for elective device exchange or planned lead revision between without local or systemic infections were selected as controls
CIED systemic infection	procalcitonin blood test	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.

Primary Outcome Measures

Name	Time	Method
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