Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

Ottawa Hospital Research Institute

Status: Completed

Conditions: Renal Failure

Treatments: Procedure: Buttonhole needling technique

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01962025

20130148

Details and patient eligibility

About

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

Full 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

Enrollment: 14 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Buttonhole needling technique

Active Comparator group

Description:

the intervention is the Buttonhole needling technique for home hemodialysis

Treatment:

Procedure: Buttonhole needling technique

Step Ladder Group

No Intervention group

Description:

Patients will use step ladder needling technique