Study compares overnight dialysis to treatment in centers

03/09/04

WINSTON-SALEM, N.C. – A Wake Forest University Baptist Medical Center nephrologist will lead a national research study in patients with chronic kidney disease to test whether six-times-a-week home dialysis at night works as well or better than three-times-a-week dialysis in a dialysis center.

The study involves hemodialysis, a type of artificial kidney treatment where the blood is cleaned by a kidney dialysis machine. It is the most common form of dialysis. It is also known as chronic dialysis therapy because the patient's kidneys have permanently failed, requiring dialysis for the rest of their lives.

Michael Rocco, M.D., the national principal investigator, said the issue to be studied is important, because "the death rate of patients receiving chronic dialysis therapy in the United States remains unacceptably high, in the range of 15 to 20 percent per year."

The study, paid for by a $3.3 million grant from the National Institutes of Health (NIH), will involve at least 10 clinical centers in the United States and Canada, including Wake Forest Baptist. The study will enroll at least 150 patients with chronic kidney disease, half randomized to six-times-per-week overnight home hemodialysis, and the other half getting the standard three-times-a-week hemodialysis in a dialysis center.

Rocco, professor of internal medicine-nephrology, said it is the first time that the NIH has paid for a study involving dialysis other than the standard three times per week. Overnight home hemodialysis is different in two important ways from standard hemodialysis provided in the center, he said. First, the patient receives dialysis six times per week instead of three times per week, so there is less buildup of the toxins ordinarily removed by healthy kidneys. Second, the patient is on dialysis for six to nine hours overnight at home instead of three to five hours at a dialysis center.

"The result of this longer time on dialysis is that the dose or intensity of the home dialysis is two to three times greater than the dose provided by standard in-center dialysis," Rocco said.

The researchers will determine whether this higher dose of dialysis will change rates of hospitalization and improve blood pressure, blood counts, diet or quality of life. G. John Chen, M.D., Ph. D., assistant professor of public health sciences-social sciences and health policy, will assist in developing an economic analysis of the costs of the two different forms of dialysis.

John M. Burkart, M.D., professor of medicine-nephrology, will direct the portion of the study at Wake Forest Baptist, which will involve 13 dialysis centers: in Winston-Salem, High Point, Lexington, Thomasville, Mt. Airy, King, Elkin, Statesville and Lake Norman.

The other clinical centers include Lynchburg Nephrology in Lynchburg, Va; Rubin Dialysis Center in Saratoga Springs, N.Y.; The Dialysis Clinic in Kansas City, Mo; Rogosin Institute in New York City; University of Western Ontario in London, Ontario, Canada; Indiana University in Indianapolis, Ind.; Washington University –St. Louis in St. Louis, Mo; the University of Iowa in Iowa City, Iowa, and Metabolic Associates in New Haven, Conn.

The study is scheduled to begin accepting patients in the fall of 2004.

Source: Eurekalert & others

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