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
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure||Procedure: Buttonhole needling technique||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
- Cost [ Time Frame: 12 Months ]Will incorporate the cost of training and complications
- 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).
- 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.
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
|Calgary, Alberta, Canada|
|London Health Sciences Centre|
|London, Ontario, Canada|
|Ottawa, Ontario, Canada, K1H 7W9|