Trial Outcomes & Findings for Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis (NCT NCT01962025)
NCT ID: NCT01962025
Last Updated: 2020-09-29
Results Overview
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.
COMPLETED
NA
14 participants
2 years
2020-09-29
Participant Flow
Participant milestones
| Measure |
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.
|
Step Ladder Group
Patients will use step ladder needling technique (i.e., sites will be rotated with needles placed at least 2-3cms between needle tips).
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis
Baseline characteristics by cohort
| Measure |
Buttonhole Needling Technique
n=8 Participants
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.
|
Step Ladder Group
n=6 Participants
Patients will use step ladder needling technique (i.e., sites will be rotated with needles placed at least 2-3 cms between needle tips).
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Etiology renal disease
Diabetes mellitus
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Etiology renal disease
Polycystic kidney disease
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Etiology renal disease
Glomerulonephritis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Etiology renal disease
Other
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
End Stage Renal Disease (ESRD) Vintage
|
8.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
6.0 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
6.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Previous access
Had 1 Central Venous Catheter (CVC)
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Previous access
Had >1 CVC
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Previous access
No CVC
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Previous access
Had 1 Arteriovenous Fistula or Graft (AVF/AVG)
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Previous access
Had 1+ AVF/AVG
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Previous access
No AVF/AVG
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
Buttonhole Needling Technique
n=8 Participants
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
|
Step Ladder Group
n=6 Participants
Patients will use step ladder needling technique
|
|---|---|---|
|
Feasibility of Participant Recruitment and Site Coordination
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Intent to Treat (ITT)
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
Outcome measures
| Measure |
Buttonhole Needling Technique
n=8 Participants
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
|
Step Ladder Group
n=6 Participants
Patients will use step ladder needling technique
|
|---|---|---|
|
Participant Training Time
|
19 days
Standard Deviation 5
|
29 days
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: No formal costing information was collected as the data linkages were not established for the feasibility trial period.
Will incorporate the cost of training and complications
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intent to Treat (ITT)
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).
Outcome measures
| Measure |
Buttonhole Needling Technique
n=8 Participants
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
|
Step Ladder Group
n=6 Participants
Patients will use step ladder needling technique
|
|---|---|---|
|
Number of Participants With Complications
Hematoma
|
1 Participants
|
5 Participants
|
|
Number of Participants With Complications
Infection - local and systemic
|
0 Participants
|
0 Participants
|
|
Number of Participants With Complications
Contact dermatitis
|
3 Participants
|
1 Participants
|
|
Number of Participants With Complications
Stenosis Requiring Angioplasty
|
4 Participants
|
3 Participants
|
|
Number of Participants With Complications
Aneurysm
|
3 Participants
|
0 Participants
|
|
Number of Participants With Complications
Radiologic/surgical interventions
|
2 Participants
|
0 Participants
|
|
Number of Participants With Complications
Re-training for needle insertion difficulties
|
0 Participants
|
0 Participants
|
|
Number of Participants With Complications
Missed insertions
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: baseline, end of training (2 months), and 2 months after graduating training (4 months)Population: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
Buttonhole Needling Technique
n=8 Participants
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
|
Step Ladder Group
n=6 Participants
Patients will use step ladder needling technique
|
|---|---|---|
|
Pain With Needling
|
17.4 mm
Standard Deviation 25.1
|
10.7 mm
Standard Deviation 7.9
|
Adverse Events
Buttonhole Needling Technique
Step Ladder Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place