October 26, 1994 The National Institutes of Health announces the beginning of a full-scale clinical trial testing the effects of higher hemodialysis doses and high-flux on dialysis patient mortality and morbidity.
Fifteen medical centers and hospitals are participating in the 7-year Mortality and Morbidity in Hemodialysis (MMHD) Trial, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The study follows a 2-year pilot project.
Lawrence Agodoa, M.D., a kidney specialist at NIDDK, explains that the high prevalence and incidence of kidney failure, rising costs, and death rates in the United States--the world's highest--were compelling reasons to conduct the study. More than 20 percent of U.S. dialysis patients die each year.
"The higher mortality among U.S. dialysis patients may be partly because we are treating older and sicker patients. But countries with lower patient-mortality also prescribe higher doses of dialysis to start with," says Dr. Agodoa. Also, many U.S. patients are inadequately dialyzed because of other factors such as shortened sessions and vascular access problems.
Participants in the MMHD Study will receive either a usual (KT/V of 1.0, double pool) or higher (KT/V of 1.3, double pool) hemodialysis dose with either a high-flux or low-flux membrane. High-flux membranes remove more of certain substances suspected of being harmful to dialysis patients.
More than 215,000 people in the United States were treated for kidney failure in 1991, about 50,000 of them for the first time. More than 70 percent of kidney failure patients are on dialysis and, of those, about 80 percent are on hemodialysis.
Study physicians and coworkers have set standards for general medical care and for factors such as diet and time on dialysis to ensure that study findings clearly result from dose and membrane interventions and not from other variations in care.
Centers are finalizing study procedures and hope to invite about 1,000 hemodialysis patients to join the trial between January 1995 and December 1997. Patients will be asked to stay in the study until the year 2000 and results should be available in 2001.
Note to Editors:
Important support for the study also comes from Baxter Engineering Group; Baxter Healthcare Corporation; Fresenius USA Inc.; R&D Labs, Inc.; Ross Laboratories; and Spectra Laboratories Inc.
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