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Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

Primary Purpose

Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Buttonhole needling technique
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Failure focused on measuring Renal failure, Hemodialysis, Canulation technique, Training time, Cost, Patient discomfort with cannulation technique

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Foothills Hospital
  • London Health Sciences Centre
  • Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Buttonhole needling technique

Step Ladder Group

Arm Description

the intervention is the Buttonhole needling technique for home hemodialysis

Patients will use step ladder needling technique

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Cost
Will incorporate the cost of training and complications
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).
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.

Full Information

First Posted
September 16, 2013
Last Updated
September 28, 2020
Sponsor
Ottawa Hospital Research Institute
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01962025
Brief Title
Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
February 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Renal failure, Hemodialysis, Canulation technique, Training time, Cost, Patient discomfort with cannulation technique

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buttonhole needling technique
Arm Type
Active Comparator
Arm Description
the intervention is the Buttonhole needling technique for home hemodialysis
Arm Title
Step Ladder Group
Arm Type
No Intervention
Arm Description
Patients will use step ladder needling technique
Intervention Type
Procedure
Intervention Name(s)
Buttonhole needling technique
Other Intervention Name(s)
Buttonhole canulation in home hemodialysis patients
Intervention Description
the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation
Primary Outcome Measure Information:
Title
Feasibility of Participant Recruitment and Site Coordination
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Participant Training Time
Description
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
Time Frame
Up to 90 days
Title
Cost
Description
Will incorporate the cost of training and complications
Time Frame
12 Months
Title
Number of Participants With Complications
Description
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).
Time Frame
12 Months
Title
Pain With Needling
Description
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.
Time Frame
baseline, end of training (2 months), and 2 months after graduating training (4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Zimmerman, MD, MSc
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada

12. IPD Sharing Statement

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Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

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