Validation of Procalcitonin as a Biomarker Diagnosing CDI ((DIRT II))

German Heart Center Munich

Status: Completed

Conditions: Cardiac Implantable Electronic Device Infections

Treatments: Other: procalcitonin blood test

Study type: Observational

Funder types: Other

Identifiers

NCT05007158

GER-EP-023

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• device associated infections

Exclusion criteria

• malignancy
• cytostatic or immunomodulating therapy

Trial design

200 participants in 4 patient groups

pocket infection

Description:

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.

Treatment:

Other: procalcitonin blood test

CIED systemic infection

Description:

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.

Treatment:

Other: procalcitonin blood test

Lead-associated infective endocarditis

Description:

Patients with infective endocarditis, diagnosed according to modified Duke criteria

Treatment:

Other: procalcitonin blood test

control group

Description:

CIED Patients presenting for elective device exchange or planned lead revision between without local or systemic infections were selected as controls

Treatment:

Other: procalcitonin blood test