Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01962025
Recruitment Status : Active, not recruiting
First Posted : October 14, 2013
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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

Condition or disease Intervention/treatment Phase
Renal Failure Procedure: Buttonhole needling technique Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : October 2013
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Buttonhole needling technique
the intervention is the Buttonhole needling technique for home hemodialysis
Procedure: 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
Other Name: Buttonhole canulation in home hemodialysis patients

No Intervention: Step Ladder Group
Patients will use step ladder needling technique



Primary Outcome Measures :
  1. Feasibility of Recruitment and Site Coordination [ Time Frame: 2 years ]
    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 definitve study. The pilot study will also allow us to see if we can coordinate mutiple sites in needling techinques and determin if we can move forward with the definitive study.


Secondary Outcome Measures :
  1. Training Time [ Time Frame: 12 months ]
    Time in Days that it takes to train participants to perform home hemodialysis (document time in days from start of training until discharge home to do self-care)Unit of measure is number of days required to independently perform home hemodialsyis

  2. Cost [ Time Frame: 12 Months ]
    Will incorporate the cost of training and complications

  3. Complications [ Time Frame: 12 Months ]
    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).

  4. Pain with needling [ Time Frame: 12 months ]
    Pain/discomfort during cannulation will be measured using a visual analogue scale at baseline, end of training, and 2 months after graduating training.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962025


Locations
Layout table for location information
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Baxter Healthcare Corporation

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01962025    
Other Study ID Numbers: 20130148
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by Ottawa Hospital Research Institute:
Renal failure
Hemodialysis
Canulation technique
Training time
Cost
Patient discomfort with cannulation technique
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Diseases
Urologic Diseases