- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02981706
Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
A Pilot Randomized Trial of Arteriovenous Fistula (AVF) Versus Arteriovenous Graft (AVG) in Elderly Patients With Advanced Chronic Kidney Disease (CKD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arteriovenous Fistula (AVF) Group
Patient will receive an arteriovenous fistula (connection between native artery and vein) as his/her dialysis access
|
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.
Other Names:
|
Active Comparator: Arteriovenous Graft (AVG) Group
Patient will receive an arteriovenous graft (synthetic connection between artery and vein) as his/her dialysis access
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Patients with Primary Access Failure
Time Frame: Up to 6 months after procedure
|
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. |
Up to 6 months after procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Number of Procedures Between the Two Groups
Time Frame: Up to 6 months after the procedure
|
The number of surgical and endovascular procedures after the initial vascular access placement measured at 6 months.
|
Up to 6 months after the procedure
|
Time to Event
Time Frame: Up to 6 months after the procedure
|
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.
|
Up to 6 months after the procedure
|
Change in Gait Speed
Time Frame: Baseline, 3 months, 6 months
|
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.
|
Baseline, 3 months, 6 months
|
Change in Grip Strength
Time Frame: Baseline, 3 months, 6 months
|
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.
|
Baseline, 3 months, 6 months
|
Change in Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: Baseline, 3 months, 6 months
|
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. |
Baseline, 3 months, 6 months
|
Change in Cognitive Screen
Time Frame: Baseline and 6 months
|
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).
|
Baseline and 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Congenital Abnormalities
- Renal Insufficiency
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Fistula
- Kidney Diseases
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Arteriovenous Fistula
Other Study ID Numbers
- AAAQ8223
- R03AG053294 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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