CIED Infection Quality Initiative Demonstration Project
ConditionInfections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.
Eligibility criteria
Qualifiers
Age ≥18 years
Cardiovascular Implantable Electronic Device (CIED) in place
Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or one positive blood culture for all other microorganisms), with no other source identified to explain the bacteremia
Cases with definite evidence of pocket infection (defined as localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage), if treated with antibiotics before culture, even with negative culture, will be considered device infection
Disqualifiers
Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and/or it is unlikely that extraction would change overall prognosis
Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection
Patients with left ventricular assist devices (LVADs)
Trial design
Treatments tested in this trial
- Multidisciplinary Team
- Outreach Visits
- Multifaceted Intervention
- Measurement and Feedback
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Duke University
Lead sponsor
Duke Clinical Research Institute
Collaborator
Philips Healthcare
Collaborator
Source ClinicalTrials.gov