Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres (HIPPO SAT) Pilot Study (HIPPO-SAT)

NCT02002169 NA UNKNOWN

Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit showering but not increase infection risk. Research question: Is it feasible to conduct a randomized control trial comparing the rate of CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC 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 STP versus standard care after meeting predefined criteria to confirm healed tunneled CVC exit site. Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the CRB rate documentation in the satellite setting, percentage of patients screened, recruited, educated successfully in the STP (intervention arm), and aspects of STP (% of contaminated patients in the control arm). Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south central Ontario, Canada. Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit sites. Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each measure of feasibility has its statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full HIPPO SAT 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 contamination.

Details

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	UNKNOWN
Enrolment	78
Start date	2012-12
Completion	2014-11

Conditions

• End Stage Renal Failure on Dialysis

Interventions

• Shower Technique Protocol
• Standard CVC Care

Primary outcomes

• Primary Feasibility Measure of the HIPPO SAT trial: Defined by 5 outcomes — 6 months
  Outcome Measures of Feasibility 1. The level of agreement between the date the nurse contacts the coordinator to inform them of a suspected infection and the date the culture was sent to the lab from the HD unit 2. The percentage of eligible patients who consent to participate in each participating satellite unit 3. The percentage of satellite HD patients with CVCs who are screened for eligibility 4. The percentage of patients in the Shower Technique arm passing the shower technique test at 3 and 6 months 5. The percentage of patients in the control arm who are contaminated i.e. using aspects of the STP such as chlorhexidine swabs at home at the exit site which they were not using at baseline

Countries

Canada