Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2019-02-11

Brief Summary

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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

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Detailed Description

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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

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Buttonhole needling technique

the intervention is the Buttonhole needling technique for home hemodialysis

Group Type ACTIVE_COMPARATOR

Buttonhole needling technique

Intervention Type PROCEDURE

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

Patients will use step ladder needling technique

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Buttonhole canulation in home hemodialysis patients

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No