MedTrace Logo

Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis

NCT02981706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-08-30

No results posted yet for this study

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

Interventions

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.

PROCEDURE

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.

Sponsors & Collaborators

Principal Investigators

  • Maya Rao, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2019-02-15
Completion
2019-02-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02981706 on ClinicalTrials.gov