Renal FailureNCT01962025
Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis
A study testing Buttonhole needling technique in people with Renal Failure, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Buttonhole needling technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2013to 11 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > 18 years old,
- Training for home hemodialysis
- Able to give informed consent,
- Arteriovenous fistula 5. Life expectancy of greater than 12 months.
Who cannot join
- 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 -
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Foothills Hospital
Calgary, Alberta
London Health Sciences Centre
London, Ontario
Ottawa Hospital
Ottawa, Ontario, K1H 7W9
About this study
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
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
Read the 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
- Conditions
- Renal Failure
- Being tested
- Buttonhole needling technique
- Keywords
- Renal failure, Hemodialysis, Canulation technique, Training time, Cost, Patient discomfort with cannulation technique
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buttonhole needling techniqueProcedure or surgery
Also called Buttonhole canulation in home hemodialysis patients
the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation
| Study group | Role | What they receive |
|---|---|---|
| Buttonhole needling technique | Active comparator | the intervention is the Buttonhole needling technique for home hemodialysis Receives: Procedure: Buttonhole needling technique |
| Step Ladder Group | No intervention | Patients will use step ladder needling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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
Measured: Up to 90 days
Cost
Will incorporate the cost of training and complications
Measured: 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).
Measured: 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.
Measured: baseline, end of training (2 months), and 2 months after graduating training (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2017
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Deborah Zimmerman, MD, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962025
- Sponsor's protocol ID
- 20130148
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2013
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01962025
- Acronym / sponsor ID
- 20130148
- Conditions
- Renal Failure
- Keywords
- Renal failure, Hemodialysis, Canulation technique, Training time, Cost, Patient discomfort with cannulation technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Oct 2013
- Primary completion
- Nov 2017 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Posted 29 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buttonhole needling technique | Active comparator | Procedure: Buttonhole needling techniquethe intervention is the Buttonhole needling technique for home hemodialysis |
| Step Ladder Group | No intervention | –Patients will use step ladder needling technique |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients > 18 years old,
- Training for home hemodialysis
- Able to give informed consent,
- Arteriovenous fistula 5. Life expectancy of greater than 12 months.
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buttonhole needling techniqueAlso: Buttonhole canulation in home hemodialysis patientsthe intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation | Procedure or surgery | Buttonhole needling technique |
Primary outcome
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.
4 secondary outcomes
Participant Training Time
Time frame: Up to 90 days
Cost
Time frame: 12 Months
Number of Participants With Complications
Time frame: 12 Months
Pain With Needling
Time frame: baseline, end of training (2 months), and 2 months after graduating training (4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Zimmerman, MD, MSc principal investigator
Ottawa Hospital Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buttonhole needling technique in people with Renal Failure, run by Ottawa Hospital Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Participant Recruitment and Site Coordination (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.