Skip to main content
OpenTrials
Completed

NCT Number: NCT02981706

Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Endstage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arteriovenous fistula (AVF)

Procedure

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: AVF

Arteriovenous Graft (AVG)

Procedure

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: AVG

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2016
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.