Ultrasound Instrument to Prevent Dialysis Graft Failure
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/29/2017 |
| Start Date: | February 27, 2006 |
| End Date: | April 30, 2008 |
New Doppler Instrument for Preventing Impending Access-Graft Failure Randomized Trial
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.
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.
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.
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.
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
We found this trial at
2
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