Ultrasound Instrument to Prevent Dialysis Graft Failure

This research study aims to show that a newly developed investigational Doppler instrument can reliably measure blood flow in dialysis access grafts, to see if a decrease in the flow may be a sign of impending graft failure and also to see if there is evidence that by monitoring the flow in these grafts their lives may be extended.

The new investigational device is to be known as FloMon; this is an ultrasonic device that provides blood flow measurements from a small probe placed in a noninvasive manner above the graft or blood vessel. The instrument is being developed so that it may help give insight to on-coming graft failure which may be prevented.

The FloMon is an extension of a previously Food and Drug Administration (FDA) cleared instrument, Echoflow-A, which had been used in a similar study as this one. The Echoflow-A is similar to this device in all respects with the exception of design and calculation of measurement. The FloMon compared to the Echoflow-A is better ergonomically designed and reads flow readings in about 2 minutes versus twice the time necessary to take similar measurements using the Echoflow-A.

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Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queens Artificial Kidney Center, Jackson Heights, New York, United States

About this study

Vascular access failure is one of the largest causes of morbidity for chronic hemodialysis patients: 16-25% of hospital admissions among United States end-stage renal disease (ESRD) patients are related to vascular access complications, and the associated cost is estimated to be over one billion dollars per year.

The most frequent cause of AV access-graft failure is thrombosis that occurs as a result of stenosis at or near the venous anastomosis. Over 50% of existing vascular access-grafts in the US are 6 mm PTFE tubes and their thrombosis rate is much higher than that of native Arteriovenous Fistulas (AVF).

Several studies have shown that early detection and repair of stenosis can prevent access thrombosis, reducing the morbidity and costs that follow thrombosis. The cost of duplex ultrasound for access monitoring is prohibitive. Blood flow, measured by indicator-dilution methods, seems to be a reliable indicator of impending access failure, but recent randomized controlled studies intended to examine this were equivocal.

This study, funded by the NIH (2R44 DK067775), is to determine if a new instrument to monitor access blood-flow can reduce graft failure and associated costs. In a pilot study using the new Doppler ultrasound instrument for weekly monitoring, conducted by the Renal Research Institute and funded by the NIH, the method predicted impending graft failure with 80% sensitivity and a false-alarm rate of less than .5/year. It measures access blood flow in less than three minutes, and uses almost no consumables.

This study is designed to test if monitoring with the new instrument improves health and reduces cost for hemodialysis patients with access-grafts.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Chronic hemodialysis patients with an AV access graft

Exclusion criteria

Anticipated change in renal replacement modality or geographic location
Inability to give informed consent
Anticipated life expectancy of less than one year

Treatment and study plan

Weekly measurement of graft flow

Other

Primary outcomes

Number of low flow events

Time frame: Mean follow-up of 15 months

A "Low-Flow Event" is an intervention, whether an angioplasty or thrombectomy, to increase graft flow.

Sponsors and collaborators

Lead sponsor

DVX, LLC

Industry

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Renal Research Institute

Registry information

Official study title

New Doppler Instrument for Preventing Impending Access-Graft Failure Randomized Trial

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Mar 31, 2006
Registry last updated: Sep 27, 2017

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.

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

Completed