CIED Infection Quality Initiative Demonstration Project

Description

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.

Conditions

Infections

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Study Overview

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Study Details

Study overview

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.

The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project

CIED Infection Quality Initiative Demonstration Project

Condition
Infections
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern, Chicago, Illinois, United States, 60611

Charlotte

Atrium Health, Charlotte, North Carolina, United States, 28203

Greensboro

Moses Cone, Greensboro, North Carolina, United States, 27401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Chris Granger, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Sean Pokorney, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

2025-12-31