Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

Not Applicable

Completed

Brief Summary: The purpose of the pilot study is to determine: 1) Will patients agree to be randomized to two different methods of putting needles in their arteriovenous fistula and, 2) if we can adequately coordinate all of the sites to get useful multicentre trial data

Detailed Description: To determine the feasibility of 1) randomizing patients to step-ladder versus buttonhole cannulation techniques, and 2) coordinating the multiple Canadian sites that are required for the definitive study.

Secondary Objectives: To determine 1) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced training time for high dose home hemodialysis patients, 2) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced overall cost, 3) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced complications (infection - local and systemic, radiologic/surgical interventions, re-trains for needle insertion difficulties, hematoma formation, aneurysm formation, missed insertions), and 4) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced patient discomfort with needling for intensive home hemodialysis patients

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Potential to be lost from the program within 12 months of training (planned living donor transplant, transfer to peritoneal dialysis (PD) or move from training centre catchment area),
Allergy to mupirocin,
Short segments or aneurysms within the arteriovenous fistula (AVF) that the attending nephrologist believes require buttonhole cannulation.,
Mechanical heart valves,
Patients who require intradermal lidocaine for needle insertion -

Arm && Interventions

Group	Intervention	Description
Buttonhole needling technique	Buttonhole needling technique	the intervention is the Buttonhole needling technique for home hemodialysis

Primary Outcome Measures

Name	Time	Method
Feasibility of Participant Recruitment and Site Coordination	2 years	The percent of qualified patients enrolled in the study for the pilot study to be successful will be ≥70%. If we can not reach this target we will not move forward with the definitive study. The pilot study will also allow us to see if we can coordinate multiple sites in needling techniques and determine if we can move forward with the definitive study.

Secondary Outcome Measures

Name	Time	Method
Participant Training Time	Up to 90 days	Time in Days that it takes to train participants to perform home hemodialysis (document time in days from start of training until discharge home to do self-care). Unit of measure is number of days required to independently perform home hemodialysis
Number of Participants With Complications	12 Months	To determine whether buttonhole cannulation, compared to step-ladder cannulation, is associated with reduced complications (infection - local and systemic, radiologic/surgical interventions, re-trains for needle insertion difficulties, hematoma formation, aneurysm formation, missed insertions).
Cost	12 Months	Will incorporate the cost of training and complications
Pain With Needling	baseline, end of training (2 months), and 2 months after graduating training (4 months)	Pain/discomfort during cannulation will be measured using a 10cm (0 mm to 100 mm) visual analogue scale, which ranges from "No Pain" (0 mm) on the left side to "Extreme Pain" (100 mm) on the right. The participant is instructed to place a mark on the scale according to the amount of pain felt during needling the fistula that day. The visual analogue scale with be completed at baseline, end of training, and 2 months after graduating training. The mean of these three assessments will be calculated.

Locations (3): Ottawa Hospital
🇨🇦
Ottawa, Ontario, Canada
Foothills Hospital
🇨🇦
Calgary, Alberta, Canada
London Health Sciences Centre
🇨🇦
London, Ontario, Canada