Questions & Answers about the Frequent Hemodialysis Network (FHN) Daily Trial
November 2010
What are the key results?
People with kidney failure who went on hemodialysis six times a week versus the standard three showed improved heart size – called left ventricular mass – and reported their physical health improved as well, compared to people who followed the conventional guidelines. The six times a week visits were also associated with improved control of high blood pressure and of excessive phosphate in the blood – which can cause a lowering of blood serum calcium – both common problems in patients who receive hemodialysis.
However, patients who had six treatments a week were also more likely to undergo treatment for vascular access problems, perhaps because of the increased punctures for the additional dialysis treatments.
If I go on dialysis six times a week versus three, will I feel better? How and how not?
You may – controlled blood pressure and improved heart size are both helpful in maintaining health. However, different people have different reactions. This study included 245 patients over more than four years, a relatively small number, so it’s likely more research may be necessary to bear out this finding.
Who do these results apply to?
These results may apply to the nearly 400,000 people in the United States and 2 million people worldwide who depend on dialysis, and the many more who may follow them. Mortality rates for those receiving dialysis for advanced kidney disease are still high, and finding ways to maintain and improve health and overall quality of life are crucial in the fight against kidney disease.
The results also may indirectly affect these people’s medical practitioners, insurers, caregivers, loved ones and anyone else involved in the care of people suffering from kidney disease or diseases like diabetes, which can lead to kidney disease.
What should a patient who received dialysis or a doctor who treats kidney disease do now?
At this point, we’ve reached a finding – not yet a recommendation for a widespread change in treatment. Though this may not yet be ready for current changes in practice, it may be significant for future research and treatment.
Is this result definitive?
Because of the relatively small sample size (245 patients), results were clear but may not yet be definitive. More research may be necessary.
Would this treatment cost more than the current protocol? How much? Will Medicare/Medicaid pay for it?
While individual treatments may be shorter, there will be more time spent on hemodialysis overall during each week, which may increase costs. At this point, as the clinical finding is not yet ready for expansion into widespread practice, decisions regarding insurance and other logistical concerns have not yet been made.
Would these results also apply to people who do hemodialysis at home?
This research was completed with patients at hemodialysis facilities at 10 universities and 54 community-based facilities in North America. Since the study did not include home hemodialysis, the results cannot be easily translated to home dialysis.
Will patients realistically be able to commit to six days a week?
Issues including costs, time and transportation all complicate the equation, but patients who participated in the study were able to maintain an average attendance of 5.2 times a week – indicating a dramatic increase over the standard treatment of three times a week, but not reflecting perfect attendance.
What are the strengths and limitations of the study?
The strengths of the study are that it occurred over a significant period of time – from January 2006 to March 2010. Patients in the study were selected at random to participate in six versus three weekly visits, so improved results across the six-times-a-week group could more accurately be attributed to the treatment, rather than the individuals selected. The limitations of the study include its relatively small sample size of 245 patients.
How much did this study cost NIDDK?
The study cost approximately $15 million, with additional funding and supplies from CMS, dialysis companies, and dialysis providers via the Foundation for NIH.