Hemodialysis Infection Prevention using Polysporin Ointment with Shower Technique in Satellite Units (HIPPO-SAT) Pilot Study Design

Abstract

Background: Hemodialysis patients are often advised not to shower if they have a central venous catheter (catheter). We developed a shower technique catheter protocol for hemodialysis
patients with healed catheter exit sites, designed to permit showering but not increase catheterrelated infection risk.
Research question: Is it feasible to conduct a randomized control trial comparing the rate of
catheter related bacteremia in adult satellite hemodialysis patients using the shower technique
protocol versus standard catheter care alone with 6 month follow up?
Study Design: This pilot study is a multi-centre randomized control trial. Eligible participants
will be randomized to shower technique protocol versus standard care after meeting predefined
criteria to confirm healed tunneled catheter exit site.
Primary Outcome: Feasibility will be determined by 5 outcome measures: 1) accuracy of the
catheter related bacteremia rate documentation in the satellite hemodialysis centre setting, percentage of patients 2) screened, 3) recruited, 4) educated successfully in the shower technique
protocol (intervention arm), and 5) treatment contamination of study groups.
Study Setting: In 2 academic and 3 community based satellite hemodialysis centres in south
central Ontario, Canada.
Patient Population: Adult satellite hemodialysis patients dialyzing via tunneled central venous
catheters with healed catheter exit sites.
Intervention: Shower technique protocol and standard catheter care or control (standard catheter care only).
Analysis: Each measure of feasibility has its own statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full study will be deemed feasible.
Discussion: A pilot feasibility study of the larger study is critical due to the potential challenges
associated with recruitment, compliance and participant ascertainment bias.