completed

To reduce infection after pacemaker or ICD surgery, antibiotics are used but the ideal amount and duration is unknown. Many different antibiotic strategies are used in Canada but no comparative effectiveness studies had been performed.

We did not know if the standard single dose of intravenous antibiotic is enough or if extra doses of different antibiotics before, during and after surgery help to reduce infection. Pacemaker and ICD procedures are delivered at high volume specialized centres following Standard Operating Procedures.

Because of this systemization of care, comparative effectiveness testing to improve care was tested in the systems in which they will be used. PADIT tested whether single antibiotics or additional antibiotics reduce infection best by randomizing centres, not patients, to one antibiotic strategy or another. Centres were randomized to one therapy and then cross over to the next after six months.

At one year, they were randomized again and then crossed over for a final time at 18 months. All patients at the centre received a pacemaker of ICD will receive that strategy during the study.

One-year post-implant sites to review their hospital records to determine if any endpoints were met.

Co-Principal Investigator on this study was Andrew Krahn, Professor, Head of Division of Cardiology, Department of Medicine, University of British Columbia.

Study Type

Interventional - Drug

Study Design

Randomized, Cluster Crossover.

NO. of Countries

2

NO. of Sites

28

NO. of Participants

19603

Study Period

2012-2017

Sponsor

PHRI

Canadian Institutes of Health Research (CIHR)

Back To Top