Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or intravascular leads, have become increasingly prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds of both short term and long term mortality are at least doubled in patients who suffer CIED infections, and long term survival is particularly poor in women. Optimal strategies to prevent CIED infections in high-risk patients are largely unproven. However, recent observational studies of an antibiotic-coated envelope implanted at the time of CIED procedure have shown that this strategy is associated with a low incidence of CIED infections. Other interventions to prevent CIED infections, including the use of antibiotic irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are commonly used but not supported by rigorous controlled studies. The Specific Aim of this study is to test the hypothesis that the use of the antibacterial envelope alone is noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device infections in patients with ≥2 risk factors for infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborators: Medtronic; The Cooper Health System; Thomas Jefferson University; Valley Health System
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Bacitracin; Cephalexin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Levofloxacin; Ofloxacin; Polymyxins

Criteria

Inclusion Criteria:

• Age ≥18 years old

• Able to give informed consent

• At least 2 of the following risk factors for infection:

• Diabetes mellitus

• Chronic kidney disease (estimated creatinine clearance <30 ml/min

• Therapeutic anticoagulation

• Chronic heart failure

• Chronic use of corticosteroids

• Fever ≥38° C or leukocytois (≥11,000 cells/mm3) within 24 hrs of implant

• Device revision (including generator change, or extraction)

• ≥3 leads in situ (CRT system or abandoned leads)

• Early reoperation (pocket re-entry <2 weeks)

• Previous CIED infection

Exclusion Criteria:

• Medical condition that is likely to be fatal in less than one year

• Emergent CIED procedure

• Allergy to rifampin or minocycline, Allergy to polymyxin-B or bacitracin

• Enrollment in WRAP-IT trial

• Current CIED pocket infection