Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
Primary Purpose
Chronic Kidney Disease, Endstage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arteriovenous Fistula (AVF)
Arteriovenous Graft (AVG)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG)
Eligibility Criteria
Inclusion Criteria:
- Age 65 years or older
- Referred by nephrology provider for vascular access for hemodialysis (HD)
- Able and willing to provide informed consent
Exclusion Criteria:
- Patient is not a candidate for an AVF per surgeon
- Congestive heart failure (CHF) as defined by ejection fraction (EF) < 20%, history of heart transplant, history of ventricular assist device
- Known central venous stenosis
- Metastatic cancer or active cancer receiving chemotherapy
- Multiple Myeloma
- Vein mapping with arterial diameter ≤ 2mm and vein diameter ≤ 2.5mm or presence of stenosis or thrombosis in the draining vein
- arterial flow velocity of ≤ 40ml/min
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arteriovenous Fistula (AVF) Group
Arteriovenous Graft (AVG) Group
Arm Description
Patient will receive an arteriovenous fistula (connection between native artery and vein) as his/her dialysis access
Patient will receive an arteriovenous graft (synthetic connection between artery and vein) as his/her dialysis access
Outcomes
Primary Outcome Measures
Proportion of Patients with Primary Access Failure
Primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months.
An access determined to be unsalvageable by the vascular surgeon and requiring a new access placement will meet the primary endpoint. For subjects on HD at 6 months, self-report of successful use of the vascular access three times will be considered functional and will not meet the primary endpoint. For all subjects not on HD at 6 months, ultrasound will be performed and interpreted by the vascular surgeon, and a mature, functioning access will be defined as meeting the following criteria:1) 600ml/min blood flow, 2) 6mm diameter dilation of the access, and 3) 6mm or less depth from the skin to the access. Any vascular access that does not fulfill all three criteria will meet the primary endpoint.
Secondary Outcome Measures
Mean Number of Procedures Between the Two Groups
The number of surgical and endovascular procedures after the initial vascular access placement measured at 6 months.
Time to Event
A time to event analysis will be performed looking at the time to successful use of the vascular access. This will be defined either as self-report of being used at dialysis three times successfully or an ultrasound showing a mature, functioning access defined as meeting the following criteria: 1) 600ml/min blood flow, 2) 6mm diameter dilation of the access, and 3) 6mm or less depth from the skin to the access.
Change in Gait Speed
The average decline in meters/second between subjects who receive AVF versus AVG and also subjects who have < 2 versus ≥ 2 number of access procedures after the initial access placement.
Change in Grip Strength
Compare the average decline in kilograms between subjects who receive AVF versus AVG and also subjects who have < 2 versus ≥ 2 number of access procedures after the initial access placement. In addition, for each subject we will measure the difference in grip strength from time zero to 6 months between the ipsilateral hand and contralateral hand from the access placement. We will compare the mean grip strength difference between the ipsilateral and contralateral hand between the AVF and AVG group using a two-sample t-test.
Change in Disabilities of the Arm, Shoulder and Hand (DASH) Score
Compare the mean change in score from 0 - 100 between subjects who receive AVF versus AVG and also subjects who have < 2 versus ≥ 2 number of access procedures after the initial access placement.
The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). For this study, we will only use to the disability/symptom section score.
Change in Cognitive Screen
The difference between the number of people who go from a negative to a positive screen between the two groups (AVF vs AVG and < 2 versus ≥ 2 number of access procedures).
Full Information
NCT ID
NCT02981706
First Posted
November 30, 2016
Last Updated
August 28, 2019
Sponsor
Columbia University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02981706
Brief Title
Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
Official Title
A Pilot Randomized Trial of Arteriovenous Fistula (AVF) Versus Arteriovenous Graft (AVG) in Elderly Patients With Advanced Chronic Kidney Disease (CKD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 6, 2016 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 65 years and older referred for vascular access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of functional status including gait speed, grip strength, and self-reported function over 6 months. The primary hypothesis to be tested is that AVF placement will result in a higher proportion of primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months compared to AVG placement. In addition, the study will evaluate whether AVF placement and a greater number of access procedures will result in a greater decline in functional status as measured by the average change over 6 months in gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm, Shoulder and Hand Survey.
Detailed Description
The elderly population is the fastest growing segment of the dialysis population. A vascular access is required to perform dialysis and current guidelines support arteriovenous fistulas (AVFs) over arteriovenous grafts (AVGs) as the preferred vascular access for dialysis. However, the preferred choice of vascular access in the elderly is unclear. Older adults have higher rates of complications from AVF placement compared to AVG placement. Placement of a dialysis access and the procedures subsequently required to achieve and maintain access functionality could result in further declines of function in this already frail population and potentially reduce quality of life. High burdens of cardiovascular disease, heterogeneous life expectancy and variable health goals may make the ideal choice of vascular access different in the elderly population than the general dialysis population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Endstage Renal Disease
Keywords
Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arteriovenous Fistula (AVF) Group
Arm Type
Active Comparator
Arm Description
Patient will receive an arteriovenous fistula (connection between native artery and vein) as his/her dialysis access
Arm Title
Arteriovenous Graft (AVG) Group
Arm Type
Active Comparator
Arm Description
Patient will receive an arteriovenous graft (synthetic connection between artery and vein) as his/her dialysis access
Intervention Type
Procedure
Intervention Name(s)
Arteriovenous Fistula (AVF)
Other Intervention Name(s)
AVF
Intervention Description
The location of vascular access placement in the upper extremity will be based on pre-surgery vein mapping and the appearance of the vessels at the time of the surgery, with the most distal clinically acceptable location used. When no contra-indication is present, the vascular access will be placed in the non-dominant arm per standard of care. In this case, the vascular access will be an arteriovenous fistula, or connection between a native artery and vein.
Intervention Type
Procedure
Intervention Name(s)
Arteriovenous Graft (AVG)
Other Intervention Name(s)
AVG
Intervention Description
The location of vascular access placement in the upper extremity will be based on pre-surgery vein mapping and the appearance of the vessels at the time of the surgery, with the most distal clinically acceptable location used. When no contra-indication is present, the vascular access will be placed in the non-dominant arm per standard of care. In this case, the vascular access will be an arteriovenous graft, or synthetic connection between a native artery and vein.
Primary Outcome Measure Information:
Title
Proportion of Patients with Primary Access Failure
Description
Primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months.
An access determined to be unsalvageable by the vascular surgeon and requiring a new access placement will meet the primary endpoint. For subjects on HD at 6 months, self-report of successful use of the vascular access three times will be considered functional and will not meet the primary endpoint. For all subjects not on HD at 6 months, ultrasound will be performed and interpreted by the vascular surgeon, and a mature, functioning access will be defined as meeting the following criteria:1) 600ml/min blood flow, 2) 6mm diameter dilation of the access, and 3) 6mm or less depth from the skin to the access. Any vascular access that does not fulfill all three criteria will meet the primary endpoint.
Time Frame
Up to 6 months after procedure
Secondary Outcome Measure Information:
Title
Mean Number of Procedures Between the Two Groups
Description
The number of surgical and endovascular procedures after the initial vascular access placement measured at 6 months.
Time Frame
Up to 6 months after the procedure
Title
Time to Event
Description
A time to event analysis will be performed looking at the time to successful use of the vascular access. This will be defined either as self-report of being used at dialysis three times successfully or an ultrasound showing a mature, functioning access defined as meeting the following criteria: 1) 600ml/min blood flow, 2) 6mm diameter dilation of the access, and 3) 6mm or less depth from the skin to the access.
Time Frame
Up to 6 months after the procedure
Title
Change in Gait Speed
Description
The average decline in meters/second between subjects who receive AVF versus AVG and also subjects who have < 2 versus ≥ 2 number of access procedures after the initial access placement.
Time Frame
Baseline, 3 months, 6 months
Title
Change in Grip Strength
Description
Compare the average decline in kilograms between subjects who receive AVF versus AVG and also subjects who have < 2 versus ≥ 2 number of access procedures after the initial access placement. In addition, for each subject we will measure the difference in grip strength from time zero to 6 months between the ipsilateral hand and contralateral hand from the access placement. We will compare the mean grip strength difference between the ipsilateral and contralateral hand between the AVF and AVG group using a two-sample t-test.
Time Frame
Baseline, 3 months, 6 months
Title
Change in Disabilities of the Arm, Shoulder and Hand (DASH) Score
Description
Compare the mean change in score from 0 - 100 between subjects who receive AVF versus AVG and also subjects who have < 2 versus ≥ 2 number of access procedures after the initial access placement.
The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). For this study, we will only use to the disability/symptom section score.
Time Frame
Baseline, 3 months, 6 months
Title
Change in Cognitive Screen
Description
The difference between the number of people who go from a negative to a positive screen between the two groups (AVF vs AVG and < 2 versus ≥ 2 number of access procedures).
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65 years or older
Referred by nephrology provider for vascular access for hemodialysis (HD)
Able and willing to provide informed consent
Exclusion Criteria:
Patient is not a candidate for an AVF per surgeon
Congestive heart failure (CHF) as defined by ejection fraction (EF) < 20%, history of heart transplant, history of ventricular assist device
Known central venous stenosis
Metastatic cancer or active cancer receiving chemotherapy
Multiple Myeloma
Vein mapping with arterial diameter ≤ 2mm and vein diameter ≤ 2.5mm or presence of stenosis or thrombosis in the draining vein
arterial flow velocity of ≤ 40ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Rao, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be retained by the Columbia PI for future research use. This applies only to those subjects who consent to allow the storage and use of their data in identifiable form after completion of the study
Learn more about this trial
Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
We'll reach out to this number within 24 hrs