Overview

This trial is active, not recruiting.

Condition renal failure
Treatment buttonhole needling technique
Sponsor Ottawa Hospital Research Institute
Collaborator Baxter Healthcare Corporation
Start date October 2013
End date November 2016
Trial size 49 participants
Trial identifier NCT01962025, 20130148

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
the intervention is the Buttonhole needling technique for home hemodialysis
buttonhole needling technique 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
(No Intervention)
Patients will use step ladder needling technique

Primary Outcomes

Measure
Feasibility of Recruitment and Site Coordination
time frame: 2 years

Secondary Outcomes

Measure
Training Time
time frame: 12 months
Cost
time frame: 12 Months
Complications
time frame: 12 Months
Pain with needling
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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 PD or move from training centre catchment area), 2. Allergy to mupirocin, 3. Short segments or aneurysms within the AVF that the attending nephrologist believes require buttonhole cannulation., 4. Mechanical heart valves, 5. Patients who require intradermal lidocaine for needle insertion -

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.