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The University is one of four medical centers nationally to study the
effectiveness of a liver dialysis device for people whose damaged or failing
livers have affected the brain.
The one-year randomized control study will look at the clinical and economic
outcomes of liver disease patients who receive dialysis using the HemoTherapies
Unit, as compared with patients who receive standard medical care.
The device is the only liver-assist technology approved by the U.S. Food and
Drug Administration for hospital-based liver dialysis for people with advanced
liver disease, including those awaiting transplant. The manufacturer,
HemoTherapies Inc. of San Diego, sees the device as a "bridge treatment" to
help stabilize people awaiting liver transplant. The company also said the unit
may postpone and possibly reduce the rate of fatalities associated with serious
liver diseases such as hepatitis, cirrhosis, drug overdose and drug toxicity.
However, until now, the device's effectiveness had not been compared to
standard care in a large number of cirrhotic patients who develop acute hepatic
encephalopathy. This neurological disorder stems from toxins - mainly ammonia -
arising from the gastrointestinal tract that bypass the damaged liver and go
directly to the brain. There they can disrupt neurotransmitter function,
causing mental deterioration, including coma.
Standard medical care for acute hepatic encephalopathy involves treating the
patient with lactulose, a non-absorbable liquid that eliminates ammonia along
with stool.
"Six out of 10 times, it relieves the encephalopathy. But if it doesn't work,
we give antibiotics to eliminate ammonia-causing bacteria in the GI tract,"
said Roshan Shrestha, associate professor of medicine at the School of Medicine
and medical director of UNC Health Care's liver transplantation program.
Standard therapy takes about five days to work.
Shrestha is a principal investigator in this "post-market" study. He and
colleagues at the University, the Mayo Clinic, the University of Colorado
Health Sciences and the Medical College of Virginia Hospitals will enroll 200
patients. They will be randomized to receive either three dialysis treatments
or standard medical therapy. Researchers expect that many patients will be
drawn from the liver transplant waiting list. All patients will have been
diagnosed with at least stage 2 acute hepatic encephalopathy based on a scale
of 0 to 4 wherein 0 equals normal and 4 equals coma.
The study will compare the following end-points: survival, bridge to
transplantation, length of hospitalization and time in intensive care.
The device is a closed system, a compact cabinet on wheels that uses a patented
semi-permeable membrane to absorb nitrogen-based toxins. Patients are attached
to the unit via a catheter inserted into the femoral vein in the groin or into
a neck vein. Blood flows into the dialyzer for cleansing and is then returned
to the patient via that vein. Each treatment lasts four to six hours.
"So far, the anecdotal evidence for this indication looks pretty impressive.
But we have to see for ourselves whether the device really works," Shrestha
said. "The trial will continue for at least one year or until we enroll enough
patients."
Shrestha's co-investigators at Carolina are Michael W. Fried, Jeffrey H. Fair
and Steven L. Zacks.
Each year, more than 25 million people in the United States are afflicted with
liver and gallbladder disease and more than 26,000 die of chronic liver
diseases and cirrhosis. There are 16,000 patients on the nation's liver
transplant waiting lists, but only 5,000 livers are donated each year.
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