Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

Study Overview
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Brief Summary
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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
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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

Official Title
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Vanguard Multi-Centre Feasibility Trial to Determine if Buttonhole Versus Step Ladder Cannulation for High Dose Hemodialysis is Associated With Reduced Overall Cost

Conditions
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Renal Failure

Intervention / Treatment
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* Procedure: Buttonhole needling technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients > 18 years old, Training for home hemodialysis Able to give informed consent, Arteriovenous fistula 5. Life expectancy of greater than 12 months. 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buttonhole needling technique<br>the intervention is the Buttonhole needling technique for home hemodialysis | Procedure: Buttonhole needling technique<br>* the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation<br>* Other names: Buttonhole canulation in home hemodialysis patients;|
| No Intervention: Step Ladder Group<br>Patients will use step ladder needling technique | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Participant Recruitment and Site Coordination | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Training Time | 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 | Up to 90 days | 
| Cost | Will incorporate the cost of training and complications | 12 Months | 
| Number of Participants With Complications | 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). | 12 Months | 
| Pain With Needling | 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. | baseline, end of training (2 months), and 2 months after graduating training (4 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal failure, Hemodialysis, Canulation technique, Training time, Cost, Patient discomfort with cannulation technique