Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

• ClinicalTrials.gov Identifier: NCT01962025
• Recruitment Status: Completed
• First Posted: October 14, 2013
• Results First Posted: September 29, 2020
• Last Update Posted: September 29, 2020
• Sponsor: Ottawa Hospital Research Institute
• Collaborator: Baxter Healthcare Corporation
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

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

Condition or disease	Intervention/treatment	Phase
Renal Failure	Procedure: Buttonhole needling technique	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Study Start Date: October 2013
• Actual Primary Completion Date: November 2017
• Actual Study Completion Date: February 11, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Buttonhole needling technique; the intervention is the Buttonhole needling technique for home hemodialysis	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; Other Name: Buttonhole canulation in home hemodialysis patients
No Intervention: Step Ladder Group; Patients will use step ladder needling technique

Outcome Measures

Primary Outcome Measures :

1. Feasibility of Participant Recruitment and Site Coordination [ Time Frame: 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 :

1. Participant Training Time [ Time Frame: 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
2. Cost [ Time Frame: 12 Months ]
   Will incorporate the cost of training and complications
3. Number of Participants With Complications [ Time Frame: 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).
4. Pain With Needling [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 -

Contacts and Locations

Locations

Canada, Alberta

Foothills Hospital

Calgary, Alberta, Canada

Canada, Ontario

London Health Sciences Centre

London, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada, K1H 7W9

Sponsors and Collaborators

Ottawa Hospital Research Institute

Baxter Healthcare Corporation

Investigators

• Principal Investigator: Deborah Zimmerman, MD, MSc; Ottawa Hospital Research Institute

  Study Documents (Full-Text)

Documents provided by Ottawa Hospital Research Institute:

Study Protocol and Statistical Analysis Plan  [PDF] December 2, 2015

More Information

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01962025
• Other Study ID Numbers: 20130148
• First Posted: October 14, 2013
• Results First Posted: September 29, 2020
• Last Update Posted: September 29, 2020
• Last Verified: September 2020

Keywords provided by Ottawa Hospital Research Institute:

Renal failure; Hemodialysis; Canulation technique; Training time; Cost; Patient discomfort with cannulation technique

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Diseases; Urologic Diseases