Renal Failure
Conditions
Keywords
Renal failure, Hemodialysis, Canulation technique, Training time, Cost, Patient discomfort with cannulation technique
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
Interventions
PROCEDUREButtonhole 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
Sponsors
Baxter Healthcare Corporation
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cost | 12 Months | Will incorporate the cost of training and complications |
| 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). |
| 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buttonhole Needling Technique The intervention is the Buttonhole needling technique for home hemodialysis.
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.
In the buttonhole technique, a constant site is used for needle placement that ultimately results in a fibrous tract. Once the tract has formed blunt needles can be used instead of sharp needles for each treatment. The presence of a tract may simplify the needle insertion technique and lead to enhanced patient confidence with needle placement. | 8 |
| Step Ladder Group Patients will use step ladder needling technique (i.e., sites will be rotated with needles placed at least 2-3 cms between needle tips). | 6 |
| Total | 14 |
Baseline characteristics
| Characteristic | Buttonhole Needling Technique | Step Ladder Group | Total |
|---|---|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 13.6 | 50.8 years STANDARD_DEVIATION 16 | 50.4 years STANDARD_DEVIATION 14.1 |
| End Stage Renal Disease (ESRD) Vintage | 8.0 years STANDARD_DEVIATION 11.1 | 6.0 years STANDARD_DEVIATION 6.1 | 6.7 years STANDARD_DEVIATION 9.7 |
| Etiology renal disease Diabetes mellitus | 3 Participants | 1 Participants | 4 Participants |
| Etiology renal disease Glomerulonephritis | 0 Participants | 1 Participants | 1 Participants |
| Etiology renal disease Other | 5 Participants | 4 Participants | 9 Participants |
| Etiology renal disease Polycystic kidney disease | 0 Participants | 0 Participants | 0 Participants |
| Previous access Had 1 Arteriovenous Fistula or Graft (AVF/AVG) | 2 participants | 0 participants | 2 participants |
| Previous access Had 1+ AVF/AVG | 0 participants | 1 participants | 1 participants |
| Previous access Had 1 Central Venous Catheter (CVC) | 2 participants | 1 participants | 3 participants |
| Previous access Had >1 CVC | 4 participants | 3 participants | 7 participants |
| Previous access No AVF/AVG | 5 participants | 5 participants | 10 participants |
| Previous access No CVC | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Canada | 8 participants | 6 participants | 14 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 |
Outcome results
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.
Time frame: 2 years
Population: Intent to Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buttonhole Needling Technique | Feasibility of Participant Recruitment and Site Coordination | 8 Participants |
| Step Ladder Group | Feasibility of Participant Recruitment and Site Coordination | 6 Participants |
Secondary
Cost
Will incorporate the cost of training and complications
Time frame: 12 Months
Population: No formal costing information was collected as the data linkages were not established for the feasibility trial period.
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).
Time frame: 12 Months
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Buttonhole Needling Technique | Number of Participants With Complications | Aneurysm | 3 Participants |
| Buttonhole Needling Technique | Number of Participants With Complications | Infection - local and systemic | 0 Participants |
| Buttonhole Needling Technique | Number of Participants With Complications | Stenosis Requiring Angioplasty | 4 Participants |
| Buttonhole Needling Technique | Number of Participants With Complications | Radiologic/surgical interventions | 2 Participants |
| Buttonhole Needling Technique | Number of Participants With Complications | Hematoma | 1 Participants |
| Buttonhole Needling Technique | Number of Participants With Complications | Re-training for needle insertion difficulties | 0 Participants |
| Buttonhole Needling Technique | Number of Participants With Complications | Missed insertions | 8 Participants |
| Buttonhole Needling Technique | Number of Participants With Complications | Contact dermatitis | 3 Participants |
| Step Ladder Group | Number of Participants With Complications | Missed insertions | 6 Participants |
| Step Ladder Group | Number of Participants With Complications | Re-training for needle insertion difficulties | 0 Participants |
| Step Ladder Group | Number of Participants With Complications | Contact dermatitis | 1 Participants |
| Step Ladder Group | Number of Participants With Complications | Stenosis Requiring Angioplasty | 3 Participants |
| Step Ladder Group | Number of Participants With Complications | Aneurysm | 0 Participants |
| Step Ladder Group | Number of Participants With Complications | Hematoma | 5 Participants |
| Step Ladder Group | Number of Participants With Complications | Infection - local and systemic | 0 Participants |
| Step Ladder Group | Number of Participants With Complications | Radiologic/surgical interventions | 0 Participants |
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.
Time frame: baseline, end of training (2 months), and 2 months after graduating training (4 months)
Population: Intent to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buttonhole Needling Technique | Pain With Needling | 17.4 mm | Standard Deviation 25.1 |
| Step Ladder Group | Pain With Needling | 10.7 mm | Standard Deviation 7.9 |
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
Time frame: Up to 90 days
Population: Intent to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buttonhole Needling Technique | Participant Training Time | 19 days | Standard Deviation 5 |
| Step Ladder Group | Participant Training Time | 29 days | Standard Deviation 14 |