Clinical trial NCT01962025: 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
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: Renal failure
Hemodialysis
Canulation technique
Training time
Cost
Patient discomfort with cannulation technique
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2013-10-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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 -

Primary outcomes:
measure: Feasibility of Participant Recruitment and Site Coordination
timeFrame: 2 years
Secondary outcomes:
measure: Participant Training Time
timeFrame: Up to 90 days
measure: Cost
timeFrame: 12 Months
measure: Number of Participants With Complications
timeFrame: 12 Months
measure: Pain With Needling
timeFrame: baseline, end of training (2 months), and 2 months after graduating training (4 months)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Deborah Zimmerman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: