NIH more frequent dialysis studies in a nutshell
Study Sites
- The daily in-center study will be done in:
Los Angeles, CA
Sacramento, CA
San Diego, CA
San Francisco, CA
San Jose, CA
St. Louis, MO
New York, NY
Nashville, TN
London, Ontario, CANADA - The nocturnal home study will be done in:
Iowa City, IA (University of Iowa; PI: John Stokes, MD; Study coordinatornator: Allison Hilkin)
St. Louis, MO (Washington University School of Medicine; PI: Dr. Brent Miller; Study coordinator: Janet Riley, RN)
Saratoga Springs, NY (Rubin Dialysis Centers; PI: Christopher Hoy, MD; Study coordinator: Amy Fensterer, RD, CDN)
Lynchburg, VA (University of Virginia; PI: Dr. Robert Lockridge, Jr.; Study coordinator: Mary Pipkin, RN)
Vancouver, British Columbia, CANADA (University of British Columbia; PI: Michael Copland, MD; Study coordinators: Lina Sioson, Sally Kwan)
London, Ontario, CANADA (University of Western Ontario/London; PIs: Drs. Robert Lindsay, Rita Suri, Amit Garg; Study coordinators: Josee Champagne, Ruth Bullas)
Toronto, Ontario, CANADA (University of Toronto, Toronto General Hospital; PI: Christopher Chan, MD; Study coordinator: Margaret McGrath-Chong, RN)
Weston, Ontario, CANADA (Humber River Regional Hospital; PI: Dr. Andreas Pierratos; Study coordinator: Winnie Chan)
Small studies have found that more frequent dialysis—short daily or long nocturnal—improves health outcomes. But how can we know if these treatments are truly better than three times per week dialysis—or if the people who choose these treatments are themselves different in some way?
This question will be the focus of a pair of studies funded by the National Institutes of Health (NIH) and slated to begin in early 2006. Study results from the Frequent Hemodialysis Network (FHN) are expected in 2009. Medicare is also giving money to help pay for the added treatments for those who take part in this study.
Daily (6 times per week) in-center hemodialysis vs. conventional in-center hemodialysis
One study will compare daily in-center treatments (6 days per week; 1.5 to 2.75 hour treatments) to conventional 3 times per week in-center treatments. Patients in the U.S. and Canada will take part in the study. They will be randomly assigned (like a coin flip) to one of these two treatments, and followed for 12 months. Researchers will seek 250 patients to take part in this study.
At the start and end of the study, researchers will look at the size and shape of the patient's heart (a measure of heart health) using an x-ray test called "MRI" (magnetic resonance imaging). Physical functioning scores on a paper-and-pencil survey will be checked; these scores have been found to predict rates of hospital stays and survival. A number of other areas will also be looked at during this study. These include control of blood pressure, red blood cell counts, phosphorus level, quality of life, depression, mental function, physical activity and number of days in the hospital.
Dr. Glen Chertow of the University of California at San Francisco and Dr. Nathan Levin of the Renal Research Institute (New York, NY) are the Primary Investigators for this study.
Daily nocturnal home hemodialysis vs. conventional in-center hemodialysis
The other study will compare long nocturnal home hemodialysis (6 nights per week; at least a 6 hour treatment per night) to conventional 3 times per week in-center treatments. Patients in the U.S. and Canada who take part in the study will be randomly assigned to one of these treatments, and followed for 14 months. Researchers will seek 250 patients to take part in this study.
Patients in the nocturnal arm of the study will have a training period of about 4 - 6 weeks. To be in this study, patients must have either a partner who can help if an emergency occurs during a treatment, or must be monitored from a central site. (New York State requires all nocturnal home hemodialysis patients to be monitored). Some, but not all of the nocturnal sites will be able to do monitoring.
All of the same measures used for the daily in-center study will also be used for the nocturnal dialysis study. Dr. Mike Rocco from Wake Forest University (Winston-Salem, NC) is the Primary Investigator for this study.
What's in it for you to take part?
Most people who will take part in these studies are likely on dialysis now, doing in-center treatments 3 times per week. If you are getting treatment at one of the study clinics and are asked to be in the study, please do think about it:
- You may get a chance to try out a new treatment that you might like better.
- You will be helping scientists to learn whether longer and/or more frequent treatment is better.
- If the results are good, it may encourage insurance companies to pay for more frequent treatments.
If you are new to dialysis, taking part in the study may allow you to start off with more treatment—and a less limited meal plan and fluids. Short daily in-center and long nocturnal home hemodialysis will only be offered through the study at the clinics that are taking part in this research.
Of course, as with any research study, the choice of whether to take part is up to you, and will not affect the care you receive.
The U.S. has been doing in-center hemodialysis 3 times per week for decades. Short daily or long nocturnal hemodialysis are both options that may be more widely offered if this study can show that they improve health outcomes. And you may have a chance to make medical history.