Ultrasound Instrument to Prevent Dialysis Graft Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309348
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : September 27, 2017
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Renal Research Institute
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Other: Weekly measurement of graft flow Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: New Doppler Instrument for Preventing Impending Access-Graft Failure Randomized Trial
Actual Study Start Date : February 27, 2006
Actual Primary Completion Date : April 30, 2008
Actual Study Completion Date : April 30, 2008

Arm Intervention/treatment
Experimental: Weekly measurement of graft flow
The surveillance group was measured with the FloMon instrument weekly, and all procedures related to their access-grafts recorded
Other: Weekly measurement of graft flow
No Intervention: Control
The control group was questioned weekly with regard to their graft status and whether there had been any graft-related procedures

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309348

United States, New York
Queens Artificial Kidney Center
Jackson Heights, New York, United States, 11372
St Albans Dialysis Center
Jamaica, New York, United States, 11434
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Renal Research Institute
Principal Investigator: Nathan Levine, MD Renal Research Institute
Principal Investigator: David Vilkomerson, PhD DVX, LLC

Responsible Party: DVX, LLC Identifier: NCT00309348     History of Changes
Other Study ID Numbers: R44DK067775 ( U.S. NIH Grant/Contract )
R44DK067775 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No