Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962025
• Other study ID #: 20130148
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: February 11, 2019

Study information

• Verified date: September 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 11, 2019
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Adult patients > 18 years old,

2. Training for home hemodialysis

3. Able to give informed consent,

4. Arteriovenous fistula 5. Life expectancy of greater than 12 months.

Exclusion Criteria:

1. 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),

2. Allergy to mupirocin,

3. Short segments or aneurysms within the arteriovenous fistula (AVF) that the attending nephrologist believes require buttonhole cannulation.,

4. Mechanical heart valves,

5. Patients who require intradermal lidocaine for needle insertion -

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Procedure:
• Buttonhole needling technique
the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Baxter Healthcare Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cost	Will incorporate the cost of training and complications	12 Months
Secondary	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
Secondary	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)