Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis

NCT02981706 | Completed DMC

• 2 other identifiers: AAAQ8223R03AG053294
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Endstage Renal Disease

Keywords

Arteriovenous Fistula (AVF); Arteriovenous Graft (AVG)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean Number of Procedures Between the Two Groups

  Up to 6 months after the procedure

• Time to Event

  Up to 6 months after the procedure

• Change in Gait Speed

  Baseline, 3 months, 6 months

• Change in Grip Strength

  Baseline, 3 months, 6 months

• Change in Disabilities of the Arm, Shoulder and Hand (DASH) Score

  Baseline, 3 months, 6 months

Study Arms (2)

Arteriovenous Fistula (AVF) Group

ACTIVE COMPARATOR

Patient will receive an arteriovenous fistula (connection between native artery and vein) as his/her dialysis access

Procedure: Arteriovenous Fistula (AVF)

Arteriovenous Graft (AVG) Group

ACTIVE COMPARATOR

Patient will receive an arteriovenous graft (synthetic connection between artery and vein) as his/her dialysis access

Procedure: Arteriovenous Graft (AVG)

Interventions

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.

Also known as: AVF

Arteriovenous Fistula (AVF) Group

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.

Also known as: AVG

Arteriovenous Graft (AVG) Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Referred by nephrology provider for vascular access for hemodialysis (HD)
• Able and willing to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Arteriovenous Fistula

Interventions

Arteriovenous Shunt, Surgical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Maya Rao, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 5, 2016
• Study Start: October 6, 2016
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)