NCT01962025

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 29, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

4.1 years

First QC Date

September 16, 2013

Results QC Date

December 4, 2018

Last Update Submit

September 28, 2020

Conditions

Renal Failure

Keywords

Renal failureHemodialysisCanulation techniqueTraining timeCostPatient discomfort with cannulation technique

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (4)

  • Participant Training Time

    Up to 90 days

  • Cost

    12 Months

  • Number of Participants With Complications

    12 Months

  • Pain With Needling

    baseline, end of training (2 months), and 2 months after graduating training (4 months)

Study Arms (2)

Buttonhole needling technique

ACTIVE COMPARATOR

the intervention is the Buttonhole needling technique for home hemodialysis

Procedure: Buttonhole needling technique

Step Ladder Group

NO INTERVENTION

Patients will use step ladder needling technique

Interventions

Buttonhole needling techniquePROCEDURE

the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation

Also known as: Buttonhole canulation in home hemodialysis patients
Buttonhole needling technique

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \> 18 years old,
  • Training for home hemodialysis
  • Able to give informed consent,
  • Arteriovenous fistula 5. Life expectancy of greater than 12 months.

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foothills Hospital

Calgary, Alberta, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. Deborah Zimmerman
Organization
Ottawa HRI
dzimmerman@toh.ca
613-722-7000

Study Officials

  • Deborah Zimmerman, MD, MSc

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2013

First Posted

October 14, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2017

Study Completion

February 11, 2019

Last Updated

September 29, 2020

Results First Posted

September 29, 2020

Record last verified: 2020-09

Locations

CA(3)