Nocturnal Hemodialysis: Promising or Proven?

By Peter Laird, MD

I continue to marvel at the dialysis medical literature that in many instances completely ignores the history of dialysis. This is especially true when it comes to the subject of "alternative" dialysis strategies, such as daily dialysis or nocturnal dialysis. It is sad indeed when the pioneers of such life saving modalities are not even remembered. 

Dr. Stanley Shaldon has been overlooked for years as the original investigator of home nocturnal hemodialysis. He not only initiated the first overnight or nocturnal home dialysis treatments, but also published his results extensively in the early 1960's. We've all had access to his results for nearly fifty years!

Dr. Shaldon has reminded readers of his early work through letters to the editor in Kidney International and Blood Purification, Origin of Nocturnal Home Haemodialysis:

Dear Sir,

Precedent claims are rarely correct, thus the statement by Drs Schlapper and Diaz-Buxo in the January issue of Blood and Purification ^[1], that Uldall et al. ^[2] established the first nightly home haemodialysis program in 1993, cannot go unchallenged.  I believe that my group was the first to develop this technique 30 years earlier and that we published extensively in the period of 1963-1968 on this subject ^[3-7]. In addition, visual proof of my claim can be seen in a video of self unattended overnight home haemodialysis in 1968 by any of your readers at http://www.youtube.com/user/stanleyshaldon ^[8].

(Ed: I have updated Dr Shaldon's video link with his YouTube page URL.)

I recently read with interest another article that speaks of the promise of nocturnal dialysis, yet why is it referred to as a promising therapy nearly fifty years after its first use?

Comments

[Denise Eilers, BSN, RN]

The phrase that comes to my mind is: "Those who cannot learn from history are condemned to repeat it." To me, the historical evidence is abundantly clear. More dialysis is better. Dare to be revolutionary and actually ask patients who have experienced more and longer treatments about their overall health and especially their quality of life. They are the living and thriving evidence.

[Christopher Blagg]

Peter - you are quite right - I always give credit to Stanley for being the first to use overnight three times a week home dialysis in London in October 1964. He visited Seattle in December 1964 and told us about it and we switched our home patients to it after that. He was also the pioneer for self-dialysis in the facility in 1963.

[Miriam Lippel Blum]

I'd like to see what Kidney International response to Dr. Shaldon was. Probably silence.

[Anonymous]

It's easy to be critical, but a group of investigators has been working for years, enrolling patients in the NIH Frequent Hemodialysis Network trial of nocturnal dialysis.

You'll likely see a number of papers come out at ASN this fall regarding the outcomes.

The topic isn't being ignored, bur rather properly studied by a randomized, controlled trial paid for by the NIH.

Nephrologist Michael Flanigan once said, "It's just hard to conduct a study to evaluate utility if people already believe they know the answers and thus evade the trial when they believe it will make a difference."

[Bill Peckham]

I not sure how pointing out a historical fact can be said to be criticism.

The problem with the NIH Frequent Hemodialysis study is that it is under powered, it isn't going to provide the answers it was proposed to provide.

I'm not entirely sure what to make of the Flanigan quote but he seems to bemoan that people did not enroll in the trial and agree to be randomized because they did not want to end up in the conventional dialysis group. I wasn't asked but I believe that would be my response.

I think it would be unethical and dangerous to randomize me out of my preferred modality - frequent overnight hemodialysis - and into a minimum dose of three day a week, four hour runs.

I'm against the idea that dialyzors should risk their lives to answer a question they already know the answer to ... where is the RCT showing the efficacy of conventional dialysis in treating stage 5 CKD?

[Dori Schatell]

For that matter, where is the RCT showing that TRANSPLANT has better survival than standard dialysis? Oh. Yeah. Right. There isn't one. And there will NEVER be one because it isn't possible to randomly assign people to receive or not receive a transplant.

So, can you dismiss all of the benefits of longer and/or more frequent dialysis as related to patient selection? No. Why not? Because there are numerous studies of the SAME people switched from standard to better dialysis whose physiological parameters (everything from melatonin synthesis to cardiac function) improved. They were their own controls. How much better of a study can we possibly have than that?

The reality is, some things truly ARE common sense. More dialysis feeling more like having healthy kidneys is one of them.

[Peter Laird, MD]

I eagerly await the FHN outcomes, which will be the second such trial. The first was completed in Canada but it was likewise underpowered to answer the questions all want to know. Yet it showed clear benefits despite its small size.

I attended the ADC this year specifically to hear the update from FHN. I was disappointed that there were no interim results but as Dr. Daugirdas pointed out, they often do not reveal interim results in RCTs to prevent bias. So be it, I know other studies in the past that have done interim results without the charge of bias, but that is their choice. The issue that will be relevant is the confounding factors such as a very high rate of tobacco abuse in those that were finally randomized. The case mix will be an interesting aspect of this study in how it is interpreted.

If if the FHN completely fails to show a significant benefit contrary to the observational studies and the prior RCT by the Canadians, they will not have answered any questions, only stirred up the bag due to how underpowered the FHN is. To answer the questions that need to be answered in the minds of some people, the study would need to have more patients than the US has total on nocturnal dialysis at present.

Nevertheless, the clinical benefits shown back in the 1960s still stand as a historical testament to the nobel experiment that dialysis was intended to be, a lifesaving intervention. I applaud the pioneers of what keeps me alive today. They deserve all the credit that is due. I am personally grateful and thankful. I despise those that have hijacked this lifesaving treatment for profit only. Their shame shall likewise be a testament to history, but not one worthy of praise. As a physician, what they have done with the promise of the pioneers is one of the most shameful chapters in the history of medicine. It didn't need to be this way.

[Denise Eilers, BSN, RN]

Dr. Flanigan was my husband's nephrologist during most of the 25 years he was on dialysis. For the record: While I don't doubt the accuracy of the Dr. Flanigan quote, I do know that, thirty years ago, he was also a proponent of a well nourished patient and a believer in longer dialysis. During clinic visits, Dr. Flanigan was as interested in my husband's quality of life (golf, work, etc) as in biochemical markers. In my opinion, he is one of the nephrologists who has always had a very balanced view of CKD5 care.