Validation of Procalcitonin as a Biomarker Diagnosing CDI

NCT05007158 | Completed

• 1 other identifier: GER-EP-023
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cardiac Implantable Electronic Device Infections

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (4)

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

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

Lead-associated infective endocarditis

Patients with infective endocarditis, diagnosed according to modified Duke criteria

Other: procalcitonin blood test

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

Interventions

procalcitonin blood test OTHER

blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit

CIED systemic infection; Lead-associated infective endocarditis; control group; pocket infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients presenting with cardiac device infection CDI

You may qualify if:

• device associated infections

You may not qualify if:

• malignancy
• cytostatic or immunomodulating therapy

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 16, 2021
• Study Start: December 1, 2011
• Primary Completion: October 10, 2021
• Study Completion: November 1, 2021
• Last Updated: May 3, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share