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 ve- nous catheter (catheter). We developed a shower technique catheter protocol for hemodialysis patients with healed catheter exit sites, designed to permit showering but not increase catheter- related 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, per- centage 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 cath- eter care only). Analysis: Each measure of feasibility has its own statistical threshold for success. If the thresh- old 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.