Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis

Chronic Kidney Disease Clinical Trial

Official title:

A Pilot Randomized Trial of Arteriovenous Fistula (AVF) Versus Arteriovenous Graft (AVG) in Elderly Patients With Advanced Chronic Kidney Disease (CKD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981706
• Other study ID #: AAAQ8223
• Secondary ID: R03AG053294
• Status: Completed
• Phase: N/A
• Start date: October 6, 2016
• Est. completion date: February 15, 2019

Study information

• Verified date: August 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Disease
• Endstage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Arteriovenous Fistula (AVF)
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.
• Arteriovenous Graft (AVG)
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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months after procedure
Secondary	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.	Up to 6 months after the procedure
Secondary	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.	Up to 6 months after the procedure
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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).	Baseline and 6 months