Good News & Question about the PHD

Discussions for Patients, Family, and Friends HD For Patients
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Real soon we will be able to add another home hemo program to the data base. Our home dialysis center hopes to have their 1st patient on the PHD by the 1st of the year. It’s been a long time getting them to start a program but it’s finally here. They signed a contract with Aksys today.

This question is for Bill or anyone else who has tried nocturnal on the Aksys.
I know you need a stand alone heparin pump but were there any other draw backs that related to the machine when doing night treatments? Anyone know why they quit the study of night treatments with the Aksys. Anyone know anyone using the PHD for nocturnal dialysis?

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Hi Marty, from my point of view there were no draw backs due to the machine. The only issues I had was the feeling of having not gotten enough sleep which I think would be the same no matter which machine I used. I saw the same improvement in labs that you have reported for your Dad and other nocturnal users report. I fondly remember a week into the study being called by Doctor Blagg - he told me to eat more ice cream - he may of said phosphorus but I heard ice cream.

I’ll have to ask my home training unit if there is anyone currently doing long runs on the PHD. I don’t think they “quit" the study I think there is just a finite number of people available to participate. My impression is that it was hard to “sell” the idea of dialyzing over night to someone who felt great dialyzing 2 or 3 hours. I’ll ask if any data from the study is available to share publicly.

BTW - I made some posters for the ASN conference going on in Philadelphia - it wasn’t my data; I laid out and printed the posters from the data given to me by Dr. Blagg - I hope the data in the posters is made available soon. As we see more people allowed to try more frequent dialysis we are producing harder to dismiss data - with each new person the adta grows stronger. At some point the renal industry will have to reevaluate the ingrained three day a week dialysis regime. Did you see the decision by Kaiser in So CA? Home first!:
http://www.ikidney.com/iKidney/Community/HomeFirst.htm

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Bill writes:
I’ll have to ask my home training unit if there is anyone currently doing long runs on the PHD. I don’t think they “quit" the study I think there is just a finite number of people available to participate. My impression is that it was hard to “sell” the idea of dialyzing over night to someone who felt great dialyzing 2 or 3 hours.

We would be interested to know the stats of how many prefer to dialyze SDD as compared to SNDD, as according to patients like Pierre, one gets more bang for the buck with SND. And we would like to understand the reason that the Aksys PHD was not designed with a heparin pump to facilitate nocturnal txs.

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Here was an interesting observation. We had a nocturnal patient who switched to daily on the NxStage because he wanted less maintaince work with the machine. He was on NxStage for a while then went back to Nocturnal because he didn’t like sitting the 2.5 hrs through the treatment.

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Hi Heather

I’ve never seen any statistics about that. It’s hard to even find out the exact number of people who are on these home hemo treatments.

At the home dialysis unit I’m “attached” to, you train initially for short daily, and then you can either stay on it or you can spend 3 nights at the hospital to “convert” to nocturnal. A few decide that they like the short daily, but the overwhelming majority choose nocturnal, for good reason.

As you know, I was on short daily for 4 whole months (not just a few days), and now I’ve been on nocturnal for more than 6 months. Short was Ok and I would happily do it if I had to, but the benefits of nocturnal are so overwhelming in terms of diet/fluid and lab results that there’s just no comparison and no going back. I don’t know if it’s the same for everyone, but even a doctor who looks at my post-tx labs would not be able to tell I even have kidney failure if he didn’t know. I’m not kidding - it’s that good. There is nothing abnormal in it whatsoever. Even my creatinine is better than what most transplant recipients get. It’s perfectly normal. Moreover, I can’t know for sure, but it’s got to be better for the heart to remove fluid at the rate of 300ml/hr than it is at the much higher rates you need when doing short treatments. For me, it sure feels better.

I always found it unbearable to wait for a treatment to finish at the centre, and I kind of felt the same way even to sit for a 2 hour short daily at home during the day. With nocturnal, it doesn’t feel that long at all, even though it’s 7-8 hours. This is because once I get on at about 10:30 or 11, I fall asleep shortly after and I rarely wake up again until near the end. So it doesn’t seem as long. Yes, the first few weeks were harder in terms of sleeping all night, but I got used to it pretty quickly.

I said at the start of this message that I would happily go back to short daily if I had to. Now, when I say that, I mean 2 hours 6 days per week. There is no way in the world that I would willingly do more than 2 hours like some of the members here do. More than that and it starts feeling much like an in-centre treatment in terms of length. It would just be too long to do that day in and day out indefinitely - for me anyway. Given 2 hour short and 7 hour nocturnals, with short running at 500/400 and nocturnal running at 300/300 (dialysate pump /blood pump), this means that every single treatment runs this much blood through the dialyzer:

  • short daily: about 40-45 litres
  • nocturnal: about 120 litres

Now multiply that by 6 for the week. That’s 270 for short daily, 720 for nocturnal (7 hours tx). You can see that nocturnal is miles ahead of short daily, even though the blood pump is slower. I mean, they aren’t even in the same league.

So, this is why I prefer nocturnal. I get so used to no diet of any kind that I don’t even like to take an extra night off even though I could.

However, I wouldn’t mislead anyone. I do it because of the dietary and expected health advantages, but it does come at the sacrifice of more limited movement during sleep, and it’s a lot of trouble doing it every night. If I wake up at night and hear something, I can’t even get up to go look out the window. I miss that. In my opinion, it also requires much more attention to everything being done just so - because other than the machine alarms and the leak alarms, nobody is watching over you all night. However, the advantages greatly outweigh any disadvantages as far as I’m concerned. I’m not wedded to nocturnal, as I could switch back to short daily any time I want to. But I wouldn’t want to. Nocturnal is so good that I’m not even as enthusiastic anymore about the possibility of getting a kidney transplant. I still want it, but I know I probably won’t do as well in some respects.

To me, the type of machine is very secondary to just the opportunity of doing nocturnal. On my Fresenius, I test the water, then I turn it on (I often do this test earlier in the day). After that, it’s a simple matter of connecting only 3 tube parts: the arterial segment connects to the dialyzer and to the drain bag at the other end. The veinous connects to the dialyzer and to the drain bag also, and the saline administration line connects from the saline bag to a little connection on the arterial line. That’s all there is to it (there are some openings and closings of clamps, but it’s easy). Once that’s done, the machine does its alarm test (about 7 minutes). At the same time, I prepare my needle and gauze tray and the strips of tape. Then I do a quick manual test of the conductivity, after which I let the saline recirculate for 10 minutes (and it can be longer if I want to do something else - I just let it go on longer). While that’s happening, I weigh myself, take my temperature, measure my blood pressure and do my quick calculation of UF goal for that night. Then I put the needles in and I’m on. No matter how simple the machine, you are still going to spend the same amount of time preparing the needle “tray”, and the same amount of time putting the needles in and doing all the taping, etc. All of that together takes me about an hour, without working especially fast, and during that time, I have time to check my email, etc. I don’t have to be standing at the machine while it recirculates or while it does the alarm test.

In the morning, a couple of minutes to rinse my blood back using the machine’s pump, just a minute or so to remove each needle and 10 minutes to hold each site. After that, it takes all of about 1 minute to pull everything off the machine and throw it away. Then I set the machine to acid clean and go back to bed while it’s happening (about 15 minutes). Once that’s done (the machine tells me) I quickly set it to heat disinfect and I again go back under the blankets until it’s over (about 45 minutes). That’s it. The machine turns itself off (it doesn’t run all day like the PHD would), and I manually switch the R/O off. Then I’m free for the entire day, every day, until about 10pm.

If I consider the concurrent activity which goes on during the preparation including things that even people using NxStage have to do, my pre-tx prep is more like half an hour than an hour. On the occasional day I have to go in centre like say because my doctor ordered a Transonic, I like the fact that the machines there are identical to mine. Even the ones in the acute dialysis units in the two general hospitals are the same. I like that because I can easily operate it myself to the extent that they let me, and I know everything that is going on. I like that.

There are two ways to improve hemodialysis: frequency and length of treatment. With short daily, you get one - frequency. With daily nocturnal, you get both frequency and you get length of treatment in a big way.

Pierre

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Dad and I prefer nocturnal for the same reason that Pierre does. However, the center which is 3hrs. closer to our home is only doing home dialysis with the PHD which is why I was asking the questions about doing nocturnal on the PHD. They won’t use the Fresenius. They think it takes to long to train people on it. Not to mention then they would have to deal with RO’s. Dad is 81 and his heart has seen some wear. I would resist putting him on a fast pump speed.

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I mentioned a blood pump speed of 300ml/hr. This is standard for nocturnal hemo, but it’s really just a maximum. You could dialyze at a slower speed than that and still get better than excellent dialysis.
Pierre

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By the way, there’s something I forgot to mention in my above post about why I chose nocturnal. Initially, my nephrologist specifically said that short daily and daily nocturnal are more or less equal in terms of health. This is from a home dialysis unit which offers both short and nocturnal and which doesn’t profit from either one. Ultimately, like the choice between PD and hemo, it comes down to a lifestyle choice, ie. doing it during the night when you sleep (hopefully anyway) versus doing it during the daytime. Nocturnal takes up your night in the sense that you can’t get up or anything, but it gives you back all of your days. Short daily takes up part of your day. So, it’s a choice. Personally, I’m glad I can do either one anytime I want, and change to either as my primary method of dialysis should I feel the need to do so.
Pierre

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Pierre, What blood pump speed where you running at when you did daily during training and how long was your run?

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Dialysate 500 and blood pump 400. The principle they operate on is that short daily should add up to the same number of hours as 3 conventional treatments of 4 hours. So, because I only trained during the 5 weekdays, my short daily treatments there were 2 hours and 20 minutes each. Once I was at home doing it for 6 days per week, they shortened to 2 hours (but I could add some time to that if I had to have a UF rate greater than 1100).

For nocturnal, they don’t really care if I do 6, 7 or 8 hours, as long as they know which one I usually do.

Pierre

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Marty, my wife runs at a blood pump speed of 200 for 8-1/2 hours 6 nights/week on a Fresenius 2008K machine. This results in a blood volume processed of about 100 L/night. There have been times in the past when because of catheter problems she ran at 150. This is still quite adequate. As others have noted nocturnal produces results that are superior to short daily and one of the benefits is that you can run at gentle speeds.

Mel

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I have some info on the Aksys PHD in relation to why or why not it has a heparin pump, and why or why not it supports daily nocturnal dialysis.

[i]

There are 2 primary reasons that Aksys does not provide a heparin pump for the PHD. They are simply that the added time it would take to develop a heparin pump for the PHD and the additional costs of designing (both hardware and software) and adequately testing a heparin pump for use with the PHD in order for it to pass FDA approval would far outweigh the benifts of their doing so.

Because the Aksys PHD was the first machine of its kind (automated home dialysis machine, hot water disinfection, ultrapure dialysate, automatic priming of the Blood Supply Tubing with ultrapure dialysate, …) it was very difficult for Aksys to pass their FDA 510k submission in the first place. Like any radically new medical technology, because they were the first of their kind to seek FDA approval, it was much more difficult for them to pass their submission - the first device using any radically new medical technology always has more difficulty in passing their FDA 510k submission than other devices using similar technologies that come along after the fact.

In getting their FDA 510k submission, knowing how difficult it was, Aksys did a cost and time analysis of adding a heparin pump to the PHD and decided that the benefits of adding an automated heparin pump did not outweigh the increased costs and development time to do so (increased development costs, increased time to engineer, making it through another round of FDA approval, longer time to market, etc …).

The PHD is not intended for nocturnal dialysis for a couple of other reasons: the 15 hour time period needed by the PHD to recycle/regenerate itself between treatments, and the relativley short life (12 hours max) that newly created dialysate is viable for use. With these 2 unalterable time constraints on the current design of the PHD, it would be extrememly difficult for a person to time their nightly treatments in a way that was not too constraining and inflexible in regards to their daily life. Imagine having to start your nocturnal tx at 11:00 every night, ending it by 7:00 the next day. Imagine having to follow this schedule every night, without any flexibilty in regards to timing in order to complete a nocturnal treatment before the dialysate expired as well as finish it with enough time before the next treatment can be started

However, now that nocturnal dialysis is becoming more common than it used to be, Aksys is currently reseaching and investment the money needed to, hopefully, develop a PHD that would work well as a nocturnal machine.

==========
That’s basically how the tech I spoke with described the PHD’s lack of a heparin pump and the difficulty the current version of the PHD would have, with its current operating constraints, to be used a a daily nocturnal hemo machine.

Eston Burciaga

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Thanks for the info.

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Eston,
Others have told me by the word of PHD’s nurse ed. that while there is a limited window in order to do nocturnal txs with the PHD, that it is possible with the use of a stand alone heparin pump and it is allowable if doctor orders. Such was done in a trial.

I think I have heard that in some nocturnal programs, they like patients to keep to set hours. So, whereas it would be nice to have some flexibility, that is the way some nocturnal programs are run anyway.

From what I have also heard, it is possible to do a combination of nocturnal and short daily txs with PHD, especially should there be an alarm when the patient is out and/ or no one else is home to handle the alarm and time runs short for the PHD to regenerate/ recycle itself.

I do have my concerns about using PHD nocturnally. Should you learn anything furthur about the legitimacy of the info. that was relayed to me, please update. I am not in a program yet and desire to do primarily nocturnal txs with the option to do short daily from time to time. The ease of use of the PHD sounds so great, but I wouldn’t want to be limited to short daily txs.

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Jane said:

I think I have heard that in some nocturnal programs, they like patients to keep to set hours. So, whereas it would be nice to have some flexibility, that is the way some nocturnal programs are run anyway.

Sounds like rationalization to justify an inflexible dialysis system to me. What’s the point of doing home hemodialysis if you can’t set your own hours? Perhaps the person who told you this meant that they like to know what the duration of the treatments are. In other words, does the person do 6, 7 or 8 hour treatments normally - which is something that might in some cases be important to know. Other than that, what difference does it make what time the person starts the treatment, and why would the staff care?

I like the concept of the PHD, but its achilles’s heel when it comes to jury-rigging it for nocturnal hemo is that 15 hours it runs every day just to prepare itself for the next treatment. As I’ve pointed out before, this would mean that for daily nocturnal, that machine would practically be running 24 hours a day. I don’t see how a person could possibly do nocturnal this way for the long term. You would have to spend every day worrying about whether you’re going to be dialyzing that night or not. When I turn my nocturnal machine off an hour or so after coming off tx in the morning, I don’t have to worry about it until 9 or 10pm when it’s time to start setting up my next treatment. I don’t think I would want a dialysis machine running in my apartment all day long when I might not be there to watch over it. Similarly, when a technician comes in to work on it, all I need to do after is to run a disinfection for about an hour, and I’m back in business anytime I want to start my tx.

These are some of the things you don’t really think about until you’ve actually done it. Yes, I know we all say and the home dialysis staff tell us we can easily miss a treatment one day or night if we have to. However, you have to realize that by the time you know you’re going to have to skip the treatment, you could easily be 2 or more litres above your dry weight (because we don’t follow a fluid restriction on any given day). That means that until you can run that next treatment, you could be a little uncomfortable if you don’t watch what you’re drinking. It’s one thing to miss a treatment when you know ahead of time that you intend to, but it’s different when it’s unplanned.

Pierre

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A couple of things came to mind when I was reading the latest posts to this thread…

Pierre -
One thing about the PHD’s recycling period is that the 15 hours that Aksys lists as the regeneration time is not hard and fast. 15 hours is the ceiling (at least I think it’s the ceiling - it might be more of a high average). The time it takes is actually based on the water pressure coming into the PHD.

For example, my water pressure coming into my house is relatively high and, as a result, the time it takes to do a full regeneration for my PHD is only about 13 hours. I was happy when I found that out.

You are definitely right about how an unexpected missed tx can be hard on you if you are not following a fairly strict fluid restricted intake every day. Having to miss a day, unexpectedly, can really make it hard on you if you’ve got too much fluid on you. In that case, though, you could always go in to the clinic for an “emergency treatment” to get rid of the excess fluid. Having to do a treatment in-center is a real drag after doing your treatments at home, but at least it is an option if something happens.

You mentioned that you felt unfomfortable leaving the machine alone while it does it thing all day. Think of it kind of like your washer and dryer. I doubt it would bother you to leave a load of clothes washing in your washer while you were out for the day. It’s kind of like that. Except for the occassional alarms that almost always happen at the end of its regeneration, it’s just a “start it and leave it alone until it’s done” kind of thing.

I have learned after using the PHD for several months now, that 99% of the alarms that occur that require attention happen during the final 30 minutes of the PHD’s regeneration. So I feel very comfortable leaving my PHD all day/night long alone while it does its thing because I am pretty confident that if it deos have any prblems, it won’t have until the end.

When I have required a tech to come out and work on my PHD, I would say that about 75% of the time, once they finished working on it, my treatment was only pushed back by an hour or so. Sometimes, their work did require cancellation of the treatment for that day, but not usually.

Maybe when Jane was talking about having to dialyze at specific times on some nocturnal programs she was talking about in-center nocturnal. That would make sense to me since the clinic has to have the staff on-hand while you are dialyzing.

Jane -
Yes, it would be possible to do nocturnal with an external heparin pump. Bill was in a nocturnal trial for Aksys when they were looking into it - I am sure he can give you specifics of how it is done.

Depending on how fast the PHD were able to complete its long regeneration routine in-between treatments, it may or may not be relatively easy to regularly do noctural with the PHD. Let’s say that the PHD regenerated in 14 hours for your location (a moderate water pressure). Assuming there were no alarms, or anything else that increased the time from 14 hours - like having change the Blood Tubing Set & Kidney, you would have 10 hours left that you could use for sleeping and dialyzing in. That would work just fine, because even if you wanted to use the full 10 hours for dialyzing you would easily fall in the 12 hour period that the dialysate is viable for use in. More realistically, let’s say you wanted to go for 8 hours, instead of 10. That would give you a lee-way of 4 hours you would have before the dialysate expired.

The tricky part would be finding out extacly how flexible you could be, given the time constraint imposed by the PHD. The numbers work on the surface, like I described above, but in reality, timing everything is much trickier. Because the dialysate is only good for 12 hours, you have to tell the PHD what time you would like your next treatment to be started. Once that happens, the PHD times is regeneration cycle to be longer if it needs to be in order to make sure that the dialysate is not created until right at the last moment, based on what time you told it you wanted to dialyze next. It does this in order to give you a full 12 hours in which to complete your dialysis from the time you told it you were going to dialyze. That way if something unexpected comes up on your schedule for that day and you can’t get on until 5 hours later than you originally told it you wanted to get on - you’d still be okay, but you could only get 7 hours of dialysis in before the dialysate expired and you had to stop.

Timing the required time for regneration between treatments, the actual start time of the treatment, and the actual length of the treatment (nocturnal or short) are alll affected by each other. It’s like a small puzzle that you have to think about if you want things to be really flexible. If you never change your start and stop times, then once you have it figured out and you stick to that schedule, it generally wouldn’t be a problem.

Nocturnal can definitely be done (even switching between nocturnal and short), but that required lengthy regeneration time between treatments just makes is more complicated than it is with a traditional machine that can basically be started and stopped whenever you want it to be.

Fortunately, like I told Pierre, almost all of the alarms that may occur happen in the last hour or so of regeneration and only push the time table back by about an hour. You could definitenly work with that if you were using the PHD for nocturnal.

Nocturnale with the PHD can definitely be done, just make sure that you fully understand the relationships between the length of the tx, start/stop times of the tx, 12 hour dialyste expiration period, and the 15 hour (or less, depending) regeneration period of the PHD.

I say “Go for it.”

I would probably be doing nocturnal with the PHD myself if my living situation was condusive to it. Unfortunately, my husband is an incredibly light sleeper and the PHD makes too many strange noises during treatments. I would have to do a heavy duty sound proofing job on Bertha (my PHD) before I could have her running next to our bed. Maybe someday.

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I think I have heard that in some nocturnal programs, they like patients to keep to set hours. So, whereas it would be nice to have some flexibility, that is the way some nocturnal programs are run anyway.

I think that the programs that care the time of day (or night) that you dialyze are those that require remote monitoring and have to have staff at a location to monitor multiple patients who are all dialyzing at approximately the same time on the same days. Fresenius was doing remote monitoring at one time, but I’m not sure if nocturnal home hemo patients with Fresenius are still being monitored. If anyone on this message board is at a clinic that remotely monitors patients, let us know if all patients at your clinic doing NHHD must do it at the same time on the same days.

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We are monitored remotely. The answer to your question is NO we don’t have to all dialyze at the same time. The monitoring staff works 7pm to 7am so they would like you to dialyze within those hrs. And it is monitored 6 nights a weeks. Saturday Nights is a night off for everyone. The only flexibility in the nights is if you dialyze 5 nights a week you can take off any extra night you want along with Saturday.

19

Eston writes:

Maybe when Jane was talking about having to dialyze at specific times on some nocturnal programs she was talking about in-center nocturnal. That would make sense to me since the clinic has to have the staff on-hand while you are dialyzing.

No, I was speaking of at home. I was coming from the standpoint that it would seem like there is not that much flexibility in nocturnal txs., anyway, as one has to get in bed about the same time every night if he wanted to get up by a decent hour. The flexibility is lost with nocturnal txs, anyhow, as one must give up waking up when it naturally occurs. It’s like going to a job- one must get up when the alarm clock goes off- there’s no sleeping in. That’s the price if one wants to have a free diet, free days and gentle txs. So, I really don’t see where there’s much flexibility in nocturnal txs, anyway.

Eston writes:

Yes, it would be possible to do nocturnal with an external heparin pump. Bill was in a nocturnal trial for Aksys when they were looking into it - I am sure he can give you specifics of how it is done.

I am not clear on this part. This is not FDA approved from what I’ve read. I’ve asked Bill about the trial and he said all went just fine. And I’ve heard that Aksys says it is ok to use an external heparin pump with a doctor’s order/ approval? But is a doctor going to take responsibility for this especially when not a single home patient is doing this?

I read your post over serveral times and still not sure I understand the timing you spoke of, fully, but I see what you mean about alarms occuring ususally in the last hour. So, if one is aware of all the timing issues, it would seem it is possible to do nocturnal txs.

How about the flushing technique the machine uses- would it be a problem to use it all through the night? Does it ever feel a little harsh on your system with short txs such that it would need to be adjusted for long txs?

20

Seems like I read in another post that there is flexibility in the number of hours that someone on NHHD can be on dialysis and that people have figured out work-arounds so they can sleep somewhat longer if they want to. You might want to do a search to see if you can find this posting.

Everything in life is a trade-off. This is true of every treatment for kidney failure that exists today. Some people choose to give up some freedom at night to have freedom during the day. Some people choose to give up knowing their own body and running their own treatment at a time they choose to be able to have someone at a clinic take responsibility for them. Some people choose to have a transplant while others choose to stay on dialysis because they’d rather deal with the known than the unknown.

You’re right when you say dialysis is like a job. I used to tell new patients starting on in-center hemodialysis that dialysis was like going to a part-time job. You don’t get paid in cash, but in living longer. If you do NHHD, you do give up freedom at night, but according to what I’ve read on this message board, they talk about freedom during the day, a more liberal diet, taking fewer (spending less on) drugs, and feeling healthier than when they did other treatments.

I get the sense that you’re struggling to make the right choice. The question you must answer for yourself…and no one else can answer it for you…is what fits best with your lifestyle and with your health needs. I suggest making a pros and cons list to help you decide this. No matter what anyone says, what is right for one person may not be right for you. In your pros and cons list, be sure to include anything that’s important to you – lifestyle, cost, convenience, and anything else you can think of. You can look at the Compare chart under the types of treatment on the Home Dialysis Central home page to give you a starting point for this list.

Remember, if you decide later that you don’t like whatever choice you make now, in most cases you can change to something else. Ask any “old-timer” and most will tell you they’ve been on most, if not all, types of treatment for kidney failure.