Improving care for infections related to heart devices
The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project
This study is testing a new approach to improve the care and treatment for patients with infections related to heart devices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT05471973 on ClinicalTrials.gov |
What this trial studies
This initiative aims to enhance guideline-driven care for patients with infections related to cardiovascular implantable electronic devices (CIED). A multidisciplinary team will implement a multifaceted intervention over six months, focusing on improving early identification, diagnosis, and treatment of CIED infections. The project will collect retrospective data before the intervention and prospective data for 12 months following the intervention to assess its effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this initiative are adults aged 18 and older who have a cardiovascular implantable electronic device and are presumed to have a CIED infection.
Not a fit: Patients who are not appropriate for device extraction or those who are in a do-not-attempt-resuscitation (DNAR) status may not benefit from this initiative.
Why it matters
Potential benefit: If successful, this initiative could lead to faster and more effective treatment for patients with CIED infections, potentially improving outcomes and reducing complications.
How similar studies have performed: Other studies focusing on quality improvement in infection management have shown promise, suggesting that this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Cardiovascular Implantable Electronic Device (CIED) in place * Presumed CIED infection, as defined by: 1. 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 2. 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 Exclusion Criteria: * 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)
Where this trial is running
Chicago, Illinois and 2 other locations
- Northwestern — Chicago, Illinois, United States (Recruiting)
- Atrium Health — Charlotte, North Carolina, United States (Not_yet_recruiting)
- Moses Cone — Greensboro, North Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Chris Granger, MD — Duke Clinical Research Institute
- Study coordinator: Kimberly Ward, MPH
- Email: kimberly.t.ward@duke.edu
- Phone: 9196606409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.