RECTIFY

The REview and improvement of Cardiac implanTable device InFection qualitY initiative (RECTIFY) Demonstration Project. 

Objective

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 (1) early identification and diagnosis (2) appropriate treatment, and (3) faster time to treatment of CIED infection. 

  1. Inclusion

    • Age ≥18 years.
    • 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. 
  2. Exclusion

    • 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).
Enrolling

Additional Info

Ethics ID: REB24-1401

ClinicalTrials.gov ID: NCT05471973

 

Sponsor: Duke University

 

PI: Dr. Derek Chew

 

Admin: Nirav Bhagat

Phone: 403 210 3996

Email: nirav.bhagat1@ucalgary.ca