The first major National Institutes of Health (NIH) clinical trial for dialysis in over 20 years confirms that the minimum dose recommended by treatment guidelines is adequate and, in general, a higher dose and special filters provide no added benefit to patients.
High death rates and frequent hospitalizations among hemodialysis patients was the major impetus for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to fund the landmark Hemodialysis (Hemo) Study.
People who received a dialysis dose higher than the minimum recommended or who used high-flux filters neither lived longer nor stayed out of the hospital longer than people who received the standard dose or used low-flux filters, announced lead Hemo Study investigator Garabed Eknoyan at a National Kidney Foundation (NKF) meeting in Chicago on Sunday. This will be welcome news to hundreds of thousands of people in the United States who undergo hemodialysis, since the results support clinical practice guidelines from NKF's Kidney Disease Outcomes Quality Initiative (K/DOQI).
The HEMO Study tested the theory that high-flux filters and a higher dialysis dose might keep patients healthier and stem rising hospitalizations, deaths, and costs. Doctors at 15 medical centers recruited more than 1,800 people receiving hemodialysis. Patients agreed to be randomly assigned to high or standard dialysis doses and high- or low-flux filters, through which their blood flows. Death was the major focus of the study, but factors such as frequency of hospitalization, nutritional status and quality of life were also studied.
While the HEMO Study showed that neither more dialysis nor high-flux filters reduced hospitalizations or deaths among trial participants as a whole, findings among certain groups of patients are intriguing. Among women, the higher dialysis dose appeared to reduce the risk of death and hospitalization, and the high-flux filter appeared to reduce the risk of death among people who had been on hemodialysis longer than 3 1/2 years when they joined the study. But these issues need further study before conclusions can be drawn, cautioned Dr. Eknoyan, professor of medicine at Baylor College of Medicine in Houston.
Kidney failure is a growing problem. More people are being diagnosed each year, adding to rising medical costs that tax an already stressed system. In the United States, more than 340,000 people are on dialysis or have a kidney transplant, treatments costing $17 billion a year. And nearly 25 percent of people who are on hemodialysis die each year in the United States, where death rates from kidney failure are among the world's highest.
Researchers continue to search for better treatments, and NIDDK has begun a program to reduce the number of people developing kidney failure. The National Kidney Disease Education Program will raise awareness about the seriousness of kidney disease and its complications and the importance of prevention, early diagnosis, and appropriate management, steps that help patients fare better on dialysis should kidney failure occur. Kidney failure may be prevented or slowed, but only a fraction of people who are at high risk are screened or managed appropriately.
Baxter Healthcare Corp., Fresenius USA Inc., R&D Labs Inc. and Ross Laboratories donated products for the trial.