Ultrasound Instrument to Prevent Dialysis Graft Failure - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 30, 2006

Last Updated Date

March 4, 2009

Start Date ^†

February 2006

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00309348 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Ultrasound Instrument to Prevent Dialysis Graft Failure

Official Title ^†

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

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.

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.

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment

Condition ^†

Hemodialysis

Intervention ^†

Procedure: possible angioplasty

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

220

Estimated Completion Date

September 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309348

Responsible Party

David Vilkomerson, Ph.D., President, DVX, Llc.

Secondary IDs ^††

NIH grant SBIR#PHS2003-2

Study Sponsor ^†

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

Collaborators ^††

Renal Research Institute
DVX llc.

Investigators ^†

Principal Investigator:

Nathan Levine, MD

Renal Research Institute

Information Provided By

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

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.