NCT05007158

Validation of Procalcitonin as a Biomarker Diagnosing CDI

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
OTHER	procalcitonin blood test	blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit

Timeline

• Start date: 2011-12-01
• Primary completion: 2021-10-10
• Completion: 2021-11-01
• First posted: 2021-08-16
• Last updated: 2022-05-03