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OpenTrials
Completed

NCT Number: NCT05007158

Validation of Procalcitonin as a Biomarker Diagnosing CDI

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

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Key information

Conditions

Cardiac Implantable Electronic Device Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • device associated infections

Exclusion criteria

  • malignancy
  • cytostatic or immunomodulating therapy

Treatment and study plan

procalcitonin blood test

Other

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

Primary outcomes

  1. diagnostic value of PCT

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study title

A Prospective Case-control Validation of Procalcitonin as a Biomarker Diagnosing Pacemaker and Implantable Cardioverter Defibrillator Pocket Infection

Acronym: (DIRT II)

Important dates

Study start
2011
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2021
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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