Is more-frequent or longer HD really better than three-times-per-week dialysis, or are people who choose these treatments themselves different in some way? This question was the focus of a pair of studies funded by the National Institutes of Health (NIH) that began in January, 2006—and now we have some answers!

Short daily HD study¹

One 12-month study randomly assigned people to:

• Short daily in-center HD (5–6 days per week, 1.5 to 2.75 hours); 125 people
• Standard in-center HD (3 days per week, 2.5 to 4 hours); 120 people

At the start and end of the study, researchers looked at patients’ heart size and shape. MRI was used to measure the heart’s main pumping chamber, the left ventricle. An overgrown, too-thick chamber, known as left ventricular hypertrophy (LVH), is a leading cause of death for dialysis patients.

Those in the study also filled out a survey that asked about their physical function. These scores predict rates of hospital stays and survival on dialysis.

Other areas were also looked at, such as:

• Blood pressure
• Cognitive function
• Nutrition
• Mental health
• Bone minerals
• Anemia
• Blood pressure
• Hospitalization
• Death

The two groups did not differ significantly by age, race, gender, weight, cause of kidney failure, length of time with kidney failure, other illness, remaining kidney function, blood pressure, treatment dose, or type of access.

Of those who were assigned to short daily HD, 78% did at least 80% of the treatments.

Short daily study results

Here are the significant findings after 12 months of the study:

	Short Dialy HD	Standard HD
Left ventricular mass	16.4±2.9 grams smaller	2.6±3.2 grams smaller
Physical function	3.4±0.8 points higher	0.2±0.8 points higher
Weekly average systolic BP	9.2±1.5 points lower	0.9±1.6 points lower
Predialysis phosphorus	Down 0.64±0.14	Down 0.08±0.14

What does all of this mean? Compared to those who did standard HD, people who did short daily treatments:

• Had healthier hearts
• Felt better physically
• Had lower blood pressure and phosphorus

The researchers decided before the study started that healthier hearts and better physical functioning were the key study endpoints. This means that the short daily study was a huge success.

It is also worth noting that there were more access procedures in the short daily group—though not more access failures. Since this study was done in-center, chances are that many different staff were putting in needles or using the HD catheters. In general, the fewer people who touch an access, the longer it can last.

It is also not likely that short daily treatments will be offered in-center outside of a study. The researchers wanted to see the impact of short daily treatments without confusing the issue by having home vs. in-center. In practice, short daily treatments are most practical at home.

Next step: Advocate!

Medicare (CMS) has said for years that it was waiting for the results of this study before it could change payment policy for more-frequent HD treatments. Now the study is out, and it is time to hold CMS accountable. Dr. Barry Straube, the Chief Medical Officer of CMS, is a nephrologist. He knows how vital this study is. But, he is retiring at the end of January 2011. The next Chief Medical Officer is not likely to know as much about dialysis.

Contact Dr. Straube soon if you want to ask CMS to use the study results to end the need for medical justification for a 4th treatment per week. CMS listens to dialyzors. While short daily treatments are most often done 5–6 times a week, many clinics can make short daily treatments work if they get paid for a 4th treatment. If doctors don’t have to write a letter to CMS each time someone wants to do short daily HD, this treatment may be offered to more people—and save more lives.

You can reach Dr. Straube at:

Barry Straube, Director
Office of Clinical Standards & Quality
Chief Medical Officer
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244
.(JavaScript must be enabled to view this email address)

Nocturnal study

The second 12-month study randomly assigned people to:

• Nocturnal HD (6 nights per week, 6+ hours per treatment); 45 people
• Standard home HD (3 times per week); 42 people

This study has not yet been published. Since it was much smaller (just 87 people), the results did not reach significance, but they were all in the expected direction.

Study Sites

The daily in-center study was 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 was done in:

• Iowa City, IA
• St. Louis, MO
• Glen Falls, NY
• Lynchburg, VA
• Vancouver, British Columbia (Canada)
• London, Ontario (Canada)
• Toronto, Ontario (Canada)

References

1. The FHN Trial Group. In-center hemodialysis six times per week vs. three times per week. N Engl J Med. 2010 Nov. ePub ahead of print. Read here (Accessed 11/24/2010).

Copyright © 2010 Medical Education Institute, Inc. All rights reserved.