UNC Study To Test Liver Disease Treatment

UNC doctors will begin a study to determine the effectiveness of a new liver dialysis treatment as early as this week.

The study, which is expected to last about one year, was initiated by the introduction of the HemoTherapies unit for people with advanced liver disease. The results will influence whether UNC will begin to incorporate the device into treatments for local patients.

The HemoTherapies unit is a compact, mobile device that utilizes a filter system to remove harmful ammonia and other organic compounds from the blood. This device is used in a series of three four- to six-hour treatments vs. the five days needed for standard medical care to work.

Roshan Shrestha, associate professor of medicine, said he hopes the device will improve current liver disease treatments. "I'm hoping that this device will help our critically ill patients so that we can save lives, bridge to transplantation, and possibly shorten recovery and get them out of the hospital sooner rather than later," he said.

Shrestha, medical director of liver transplantation and principal investigator of the study, will be working with UNC doctors Michael W. Fried, Jeffrey H. Fair and Steven L. Zacks. The investigative team will cooperate with counterparts at the Mayo Clinic, the University of Colorado Health Sciences and the Medical College of Virginia Hospitals.

Originally created by HemoCleanse Inc., the device was approved by the Food and Drug Administration in April 1996, Shrestha said. The company has since been bought by HemoTherapies, which is now marketing the unit.

Despite the approval, the effectiveness of the HemoTherapies unit has not been compared with standard medical care for the treatment of large numbers of cirrhosis patients who develop acute hepatic encephalopathy.

Zacks, clinical assistant professor of medicine, said further investigation will evaluate the new treatment. "To date there is some evidence that suggests it works, but there needs to be some more rigorous studies done," he said.

Cirrhosis, or scarring of the liver, is ultimately lethal and can result in hepatic encephalopathy when the liver's amount of functioning capacity is about 15 percent of normal ability.

This lack of liver function results in the passage of toxins, such as ammonia, to the brain, which then cause inappropriate levels of consciousness. The degree of hepatic encephalopathy is measured on a scale of one to four with symptoms being various stages of consciousness, from forgetfulness to coma.

Fair, director of liver transplantation, said the standard care for patients with acute hepatic encephalopathy involves giving the patient lactulose, a liquid to eliminate the harmful ammonia along with stool. Should this procedure be unsuccessful, antibiotics are administered to eliminate ammonia-causing bacteria in the gastrointestinal tract.

Some side effects of the HemoTherapies unit are reduced platelet count and decreased blood-clotting capability.

In order to compare these two forms of dialysis treatment, Fair said 200 patients with hepatic encephalopathy levels of two or greater will be chosen, some from the national transplant waiting list, and will be randomly placed in one of the two treatment plans.

In preparation of the study, variables will first be eliminated by correcting gastrointestinal bleeding, internal bleeding, infection, dehydration, misuse of medication or a high protein diet in each of the patients. Upon completion of the respective treatments, several elements will be compared such as survival, bridge to transplantation, length of hospitalization, and time in intensive care.

"I would look at this as one long journey, and this is really just one step along the way," Fair said. "Ultimately, there are even bigger things down the road such as cell therapy that will be able to support people in more efficacious ways."

The University Editor can be reached at udesk@unc.edu.