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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buttonhole needling technique | Active Comparator | the intervention is the Buttonhole needling technique for home hemodialysis |
|
| Step Ladder Group | No Intervention | Patients will use step ladder needling technique |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buttonhole needling technique | Procedure | the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cost |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Zimmerman, MD, MSc | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Hospital | Calgary | Alberta | Canada | |||
| London Health Sciences Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to Treat (ITT) | Posted | Count of Participants | Participants | 2 years |
|
During study period - at start, 6 months and at completion of study (12 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah Zimmerman | Ottawa HRI | 613-722-7000 | dzimmerman@toh.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2015 | Dec 3, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
Will incorporate the cost of training and complications |
| 12 Months |
| 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 |
| 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) |
| London |
| Ontario |
| Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 7W9 | Canada |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Etiology renal disease | Count of Participants | Participants |
|
| End Stage Renal Disease (ESRD) Vintage | The duration of time between the first day of dialysis treatment and the day of kidney transplantation. | Mean | Standard Deviation | years |
|
| Previous access | Number | participants |
|
| OG001 |
| Step Ladder Group |
Patients will use step ladder needling technique |
|
|
| 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 | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | days | Up to 90 days |
|
|
|
| Secondary | Cost | Will incorporate the cost of training and complications | No formal costing information was collected as the data linkages were not established for the feasibility trial period. | Posted | 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). | Intent to Treat (ITT) | Posted | Count of Participants | Participants | 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. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | mm | baseline, end of training (2 months), and 2 months after graduating training (4 months) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Step Ladder Group | Patients will use step ladder needling technique | 0 | 6 | 0 | 6 | 0 | 6 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Aneurysm |
|
| Hematoma |
|
| Infection - local and systemic |
|
| Radiologic/surgical interventions |
|
| Re-training for needle insertion difficulties |
|
| Missed insertions |
|