Ultrasound Instrument to Prevent Dialysis Graft Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Renal Research Institute
DVX, LLC
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00309348
First received: March 30, 2006
Last updated: March 2, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Hemodialysis
Procedure: possible angioplasty
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: New Doppler Instrument for Preventing Impending Access-Graft Failure Randomized Trial

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • graft flow restored for dialysis [ Time Frame: immediately following intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: February 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: possible angioplasty
    possible angioplasty
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 RRI 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309348

Locations
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
Renal Research Institute
DVX, LLC
Investigators
Principal Investigator: Nathan Levine, MD Renal Research Institute
  More Information

No publications provided

Responsible Party: David Vilkomerson, Ph.D., President, DVX, Llc.
ClinicalTrials.gov Identifier: NCT00309348     History of Changes
Other Study ID Numbers: R44 DK67775, NIH grant SBIR#PHS2003-2
Study First Received: March 30, 2006
Last Updated: March 2, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014