Ultrasound Instrument to Prevent Dialysis Graft Failure
NCT ID: NCT00309348
Last Updated: 2017-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2006-02-27
2008-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Weekly measurement of graft flow
The surveillance group was measured with the FloMon instrument weekly, and all procedures related to their access-grafts recorded
Weekly measurement of graft flow
Control
The control group was questioned weekly with regard to their graft status and whether there had been any graft-related procedures
No interventions assigned to this group
Interventions
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Weekly measurement of graft flow
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to give informed consent
* Anticipated life expectancy of less than one year
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Renal Research Institute
OTHER
DVX, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Nathan Levine, MD
Role: PRINCIPAL_INVESTIGATOR
Renal Research Institute
David Vilkomerson, PhD
Role: PRINCIPAL_INVESTIGATOR
DVX, LLC
Locations
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Queens Artificial Kidney Center
Jackson Heights, New York, United States
St Albans Dialysis Center
Jamaica, New York, United States
Countries
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