Time to End the Aluminum Crises

[cassandra]

And we CAN'T sue? Not even in the US of A?

[obsidianom]

And we CAN'T sue? Not even in the US of A?

Lawsiuts are difficult to win. You must prove there was action on their part that caused damages. Just a mistake like having too much aluminum isnt enough. In court you must prove the "mistake " or action dierctly caused some type damage that can be quantified.
Yes Nxstage is responsible for the aluminum issue , they admiteed it. But the problem will be proving actual damages.
All I care is that they clean this up and IT NEVER HAPPENS AGAIN. The problem now is we dont know for sure they have actaully cleaned it up. My wifes aluminum has bee elevated severly for months on the pureflow.  If it drops significantly on the bags it tends to show there is still a problem with the pureflow. We should have a number next Tuesday on her aluminum. I will post it.

[Hemodoc]

The problem IS with the PureFlow  products made by Rockwell.

No, winning a lawsuit will likely be impossible. Our only choice is at the marketplace level when another machine is available. The Baxter Vivia is already in use in Europe and hopefully soon here in the US. I have no doubt that aluminum levels will be one of the advertising issues with Baxter against NxStage. NxStage is truly setting themselves up for failure. I have lost all trust with them and they won't get it back.

[ProStreetCamaro]

We had no idea there was an aluminum issue going on. Well we knew because my wifes nurse called and had us check some lot numbers and also had her do an aluminum test and everything came back fine. Her sak number is 306. Seems to be an oddball sak that not many people use. 450/39/25L is her setup.

[obsidianom]

We had no idea there was an aluminum issue going on. Well we knew because my wifes nurse called and had us check some lot numbers and also had her do an aluminum test and everything came back fine. Her sak number is 306. Seems to be an oddball sak that not many people use. 450/39/25L is her setup.

Sak 306 is simply a 50 liter sak with a potassium of 2 rather than 1. WE use a similar sak, 304 which is 60 liters at potassium of 2.
If you are running your blood at 450 you are going very fast and risking your fistula . Dr. Agar has written on this extensively and recommends staying below 350. WE do 340.
On Nxstage there is really no advantage to faster blood speeds. It is all about the volume of dialysate.   25 liters is low amount. My wife for example is tiny and weighs only 55 kg uses 30 liters. You may want to talk to your team about this.

[ProStreetCamaro]

We had no idea there was an aluminum issue going on. Well we knew because my wifes nurse called and had us check some lot numbers and also had her do an aluminum test and everything came back fine. Her sak number is 306. Seems to be an oddball sak that not many people use. 450/39/25L is her setup.

Sak 306 is simply a 50 liter sak with a potassium of 2 rather than 1. WE use a similar sak, 304 which is 60 liters at potassium of 2.
If you are running your blood at 450 you are going very fast and risking your fistula . Dr. Agar has written on this extensively and recommends staying below 350. WE do 340.
On Nxstage there is really no advantage to faster blood speeds. It is all about the volume of dialysate.   25 liters is low amount. My wife for example is tiny and weighs only 55 kg uses 30 liters. You may want to talk to your team about this.

She has been doing it for 2 years now without issue. Her pressures stay under 200 and her kpv (is that what it is called I forget?) stays around 2.0 to 2.4 and now that they allow urine into the formula her kpv is up in the 3.X range each month. If she does treatments any longer than 2 and a half hours it makes her very sick. Since her kidneys still function to some degree her neph agrees with her 4 day a week short treatments. She feels good and functions as if she is not sick at all. It took them months to finally agree with her at davita that she is very different than a typical dialysis patient. I will have her question them next month about the flow rate but I know she wont change it because on the rare occasion when her numbers are a bit high and we are forced to run at a lower rate it makes her feel terrible after the treatment. Her monthly in center visit was today actually. I don't know my wife's weight but she is heavy set and my guess would be around 230 pounds. She doesn't weigh herself for treatments because she doesn't retain fluid.

I had her question them today about the aluminum. Nancy (epomans former nurse) told her nobody in this region had any aluminum issues. She said it was a regional thing and my wife's blood work showed no aluminum when we tested it a month or two ago.

[noahvale]

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[ProStreetCamaro]

She has been doing it for 2 years now without issue. Her pressures stay under 200 and her kpv (is that what it is called I forget?) stays around 2.0 to 2.4 and now that they allow urine into the formula her kpv is up in the 3.X range each month. If she does treatments any longer than 2 and a half hours it makes her very sick. Since her kidneys still function to some degree her neph agrees with her 4 day a week short treatments. She feels good and functions as if she is not sick at all. It took them months to finally agree with her at davita that she is very different than a typical dialysis patient. I will have her question them next month about the flow rate but I know she wont change it because on the rare occasion when her numbers are a bit high and we are forced to run at a lower rate it makes her feel terrible after the treatment. Her monthly in center visit was today actually. I don't know my wife's weight but she is heavy set and my guess would be around 230 pounds. She doesn't weigh herself for treatments because she doesn't retain fluid.

I had her question them today about the aluminum. Nancy (epomans former nurse) told her nobody in this region had any aluminum issues. She said it was a regional thing and my wife's blood work showed no aluminum when we tested it a month or two ago.

Basically, I also agree with the philosophy - If it ain't broke, don't fix it - especially in your wife's situation since she still urinates and has some residual clearance function.  However just a couple of thoughts for you. 

The "Dr. Agar" obsidianom is referring to is John Agar, MD, a world renown nephrologist from Australia who has dedicated his practice to helping esrd patients live well with renal failure.  He is an unabashed proponent of home hemo and the concept of HDP - Hemodialysis Product - in determining dialysis adequacy.   

"kpv" is Kt/V.  It uses kinetic modeling to come up with a dialysis prescription based on urea clearance from the blood.  While accepted by the majority of nephrologists - especially those in the U.S. -  as the "gold standard" of dialysis adequacy, it is far from it.  Urea is an easily dialyzable toxin.  However, better indicators for long-term patient survivability with less dialysis related medical complications, is the clearance of β2 microglobulin and phosphorous.  General rule of thumb is a minimum of 18 hours of hemodialysis per week to accomplish this goal.

If interested, here is a link on the concept written by Dr. Agar....

http://www.nocturnaldialysis.org/opthd1.htm  - (also gives a good explanation of Kt/V and why this isn't a good indicator of optimal dialysis)

and one on HDP and dialysis adequacy from Belding Scribner, MD and Dimitrios Oreopoulos, MD - two of the "fathers of dialysis" -

http://therenalnetwork.org/qi/resources/HDP.pdf


Again, obsidianom is pretty much on target about the damage high blood pump speeds can cause to a fistula.  You can read more here - http://www.homedialysis.org/news-and-research/blog/38-dont-flog-fistulas-slow-hemodialysis-blood-flow

Final thought...Please have your wife's dialysis center give her a copy of the aluminum results just so you can see that it is "0."  If you have been keeping up with the IHD discussion threads on this topic, nxstage users from all across the country were/are having problems with the PureFlow SAKS.

May you both continue to do well! - NoahVale
 
 

Wow thank you so much for this information it is very much appreciated! I will read further into the links you posted and also show my wife when she gets back from Cali friday and have her read up on everything so we can make better informed decisions. I do know she feels very good and works 40 to 60 hours a week the way we have been doing it the last 2 years. That is why I am sure she would be hesitant to change anything. We hope that she will have a transplant in the next year as soon as she looses the rest of the weight. Her sister, myself and 5 or 6 of her friends are all going to be tested. Hopkins told us out of that many somebody will likely be a good match. Most likely her sister but we are all ready whoever it happens to be.


Oh BTW we have a baby due December 22nd! Had to use an egg donor and surrogate. None of the fertility clinics would do the procedure to retrieve her eggs.

[noahvale]

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[ProStreetCamaro]

Wow thank you so much for this information it is very much appreciated! I will read further into the links you posted and also show my wife when she gets back from Cali friday and have her read up on everything so we can make better informed decisions. I do know she feels very good and works 40 to 60 hours a week the way we have been doing it the last 2 years. That is why I am sure she would be hesitant to change anything. We hope that she will have a transplant in the next year as soon as she looses the rest of the weight. Her sister, myself and 5 or 6 of her friends are all going to be tested. Hopkins told us out of that many somebody will likely be a good match. Most likely her sister but we are all ready whoever it happens to be.

Oh BTW we have a baby due December 22nd! Had to use an egg donor and surrogate. None of the fertility clinics would do the procedure to retrieve her eggs.

Your wife is definitely not the average esrd patient.  Pregnant women on dialysis are required to get treatment at least 6 days a week. After reading the additional info about the pregnancy (congratulations!) and continuing to work 40-60 hours a week, I went back to check your introduction post.  I now have a better understanding.  So basically, the sarcoidosis caused limited kidney dysfunction?  Could also explain why her aluminum blood level shows 0, her kidneys are still filtering it out.  About your wife's weight - isn't about 25-35 pounds due to her pregnancy?  Shouldn't she be close to the target for transplant after delivery and recuperation time?  Is she being followed at Johns Hopkins for her pregnancy?  Continue to check in over here.  You never know what you'll learn.

Congrats again. - NoahVale

We had to use an egg donor and surrogate. We wanted to use her eggs but none of the fertility clinics would retrieve them. They said once she gets a transplant then they will retrieve them. Problem is my wife turns 41 in november so time is running out to use her own eggs. Her kidney function is about 8 to 10%. We had thought about trying to get pregnant but she decided against it. I was ready to help her do as many treatments as needed but she didn't want to risk it.

[Hemodoc]

Is it really time to end the aluminum crises? Well, yes of course, NxStage needs to do so quickly. However, a post today on FB on the NxStageUsers forum underscores that the "crises" continues unabated at the present time. Sure, I have heard from more than one source the rumors of a new provider for the SAKs, but hearing someing with an increasing aluminum content and wondering if they have old SAKs from the recall should have all of us looking at the fact NxStage is STILL POISONING their patients with aluminum. No, it is not over yet.


Tami Ramsey
11 hrs · Canton, GA
So, after getting my labs back this month and noticing that I was anemic...I'm usually between 10-11, even at 12 once this summer, I requested an aluminum level.
Last quarter my aluminum level was 16.3 and because my hgb was doing well, I didn't really worry about the aluminum. Today, it's 48.6! My Hgb for October was 9.4, prompting an Aranesp dose increase to 100mg.
What the heck is going on? Am I using Sak's that were recalled? Does anyone have the list still available so that I can double check? I've asked my clinic to talk with my nephrologist and see if I should switch to bags. What are your thoughts?

[obsidianom]

Is it really time to end the aluminum crises? Well, yes of course, NxStage needs to do so quickly. However, a post today on FB on the NxStageUsers forum underscores that the "crises" continues unabated at the present time. Sure, I have heard from more than one source the rumors of a new provider for the SAKs, but hearing someing with an increasing aluminum content and wondering if they have old SAKs from the recall should have all of us looking at the fact NxStage is STILL POISONING their patients with aluminum. No, it is not over yet.


Tami Ramsey
11 hrs · Canton, GA
So, after getting my labs back this month and noticing that I was anemic...I'm usually between 10-11, even at 12 once this summer, I requested an aluminum level.
Last quarter my aluminum level was 16.3 and because my hgb was doing well, I didn't really worry about the aluminum. Today, it's 48.6! My Hgb for October was 9.4, prompting an Aranesp dose increase to 100mg.
What the heck is going on? Am I using Sak's that were recalled? Does anyone have the list still available so that I can double check? I've asked my clinic to talk with my nephrologist and see if I should switch to bags. What are your thoughts?

 You are correct Peter, Nxstage really screwed up and never completely fixed the problem like they promised. My wife is still on bags and her aluminum mwhich was stuck at 40 plus is dropping fast finally.  They basically admitted that it is JUST NOW that they are fixing this. This is 5 months later then they originally stated. I have some very damning info from them that I cant repeat that convinced me they never fixed the original problem back in May. They are only now doing it .
Some people are ok on the pureflow and my guess is that has to do more with their own ability to excrete aluminum . People like my wife who cant excrete it on thier own were really poisoned. I am glad the bags work so well.
I wish the FB people would come over here and post .We could use them . I dont do facebook.


EDITED:  Fixed quote - Rerun, Admin

[Hemodoc]

Dear Dr O,

I believe that there is a much simpler explanantion on why some have no elevations, well, explanantions is more like it.

First, many nephrologists erroneously consider levels as high as 20 "normal." I suspect that is a large part of the equation.

Secondly, PiSA still makes product for NxStage and it is likely that many get their supplies through PiSA. One noted he had shipping labels from PiSA on at least one of his shipments.

Clearance of aluminum is dependent on renal function. It is likely that those who are anephric had the highest levels and those with higher levels of residual renal function ha better levels. Mine were in the 14-17 range except for one month when it hit 21 and that was when I was pushing my volumes up to 47 liters instead of my usual 40 liters. Even with these "low" levels, my Hb and my cognitive abilities took a hit for sure.

At this point, I trust nothing that NxStage states.

[obsidianom]

Dear Dr O,

I believe that there is a much simpler explanantion on why some have no elevations, well, explanantions is more like it.

First, many nephrologists erroneously consider levels as high as 20 "normal." I suspect that is a large part of the equation.

Secondly, PiSA still makes product for NxStage and it is likely that many get their supplies through PiSA. One noted he had shipping labels from PiSA on at least one of his shipments.

Clearance of aluminum is dependent on renal function. It is likely that those who are anephric had the highest levels and those with higher levels of residual renal function ha better levels. Mine were in the 14-17 range except for one month when it hit 21 and that was when I was pushing my volumes up to 47 liters instead of my usual 40 liters. Even with these "low" levels, my Hb and my cognitive abilities took a hit for sure.

At this point, I trust nothing that NxStage states.

What is interesting is my wife still has urination function . Yet she hit 44 on the serum aluminum.  So it may be more complex then we think.
My guess based on physiology is the aluminum goes into bone as we know and there is where the real issue lies. I would guess that people with higher bone turnover or in effect more metabolically active bone may end up with higher serum aluminum levels and more difficulty excreting the aluminum then people with less bone activity . My wife has a fairly high alkaline phosphatase level, above normal which indicates high bone activity. Perhaps that is why her aluminum skyrocketed to 44.  This is all conjecture.
In the end it is still all due to Nxstage having too much aluminum in th saks . Period. For now we are staying on the bags. I am mused to it now and dont mind it much now. The cardboard is actually heating our house as we burn wood for heat and cardboard burns well . I am saving on fuel costs and electricity as I dont have to heat 60 liter saks any longer.
By the way my apple trees produced over 400 pounds of quality apples this year . The dialysate as fertilizer is working wonders on my small orchard. I donated apples to the local food bank(100 pounds) as I was over run with apples.  So I am using dialysis for heat and food. My wife thinks she should get paid for having renal disease as we are saving money with the end products.

[amanda100wilson]

I cannot excrete aluminum as I do not pass any urine.  My levels have been normal.  As Obsidionom states it may have to do with bone metabolism, but maybe the explanation is that some have a better binding capacity with bome than others, which I am sure isn't good for the bones, so maybe we are also being harmed without knowing it.  Certainly, my cognitive function has gone down in the last year, and getting my Hgb. To rise has been problematic over the same period of time.  Wonder what your thoughts are about this, Peter?

[obsidianom]

I cannot excrete aluminum as I do not pass any urine.  My levels have been normal.  As Obsidionom states it may have to do with bone metabolism, but maybe the explanation is that some have a better binding capacity with bome than others, which I am sure isn't good for the bones, so maybe we are also being harmed without knowing it.  Certainly, my cognitive function has gone down in the last year, and getting my Hgb. To rise has been problematic over the same period of time.  Wonder what your thoughts are about this, Peter?

My question is, what exactly is your aluminum? "Normal" is in the eyes of the beholder. In reality as Peter has written, it should be below 5 .

[Hemodoc]

Amanda, I believe the simplest explanation is that you are getting product from PiSA which still makes SAKs and the bags. Mark Wetzel found a PiSA routing note on some of his SAKs at one point in time a couple of months ago. NxStage has a very long term contract with PiSA and is quite happy with what they produce. So am I.

Rockwell on the other hand is a horrible company in my opinion. Unfortunately, they produce a large share of dialysaate for DaVita and with their Triferric nearing FDA approval, will likely gain an even larger share. I will pass on both Triferric and in-center dialysis.

[caregivertech1]

Update....my wife's aluminum on Oct. 7 was 9 and on Nov. 5th it was 8. This is after being in the mid 20's for most of the last year and a half. Still hanging 2 bags per 30L treatment. Will go back to all Pureflow when level is 0 or less than 5. Just FYI.

[obsidianom]

Well now I am confused. My wifes aluminum went UP on bags this past month to 27 from 22. We are all confused. Any ideas? She gets no aluminum in water or diet.

[Hemodoc]

Well now I am confused. My wifes aluminum went UP on bags this past month to 27 from 22. We are all confused. Any ideas? She gets no aluminum in water or diet.

Two issues possible.

1) Simply mobilization of aluminum contained in other tissues. Serum levels are not an accurate reflection of diffuse organ contamination.

2) NxStage is now using a different supplier as well for the Bags.

That is if all other sources have been eliminated. I would think the most likely is mobilization from other tissues. It takes about a year to clear aluminum from the bones. In addition, lab variation that can depend on collection issues, transportation issues are also something to consider.

I do know that NxStage has a long term contract with PiSA until I believe 2018. I would be very surprised to see PiSA relax their standards.

Wait to see what the trends are or how they continue. I suspect it will over time continue to come down. Hopefully that will be the case.

[obsidianom]

Well now I am confused. My wifes aluminum went UP on bags this past month to 27 from 22. We are all confused. Any ideas? She gets no aluminum in water or diet.

Two issues possible.

1) Simply mobilization of aluminum contained in other tissues. Serum levels are not an accurate reflection of diffuse organ contamination.

2) NxStage is now using a different supplier as well for the Bags.

That is if all other sources have been eliminated. I would think the most likely is mobilization from other tissues. It takes about a year to clear aluminum from the bones. In addition, lab variation that can depend on collection issues, transportation issues are also something to consider.

I do know that NxStage has a long term contract with PiSA until I believe 2018. I would be very surprised to see PiSA relax their standards.

Wait to see what the trends are or how they continue. I suspect it will over time continue to come down. Hopefully that will be the case.

Thanks Peter. I kind of thought the same thing , that it might be leaching out of the bones into the blood. We did eliminate ALL other sources of aluminum. All water is Zero water and she doesnt eat as she is on a feeding tube. We only use the bags now for 6 weeks already. We are continuing only on bags. Hopefully it will drop over time. It just makes me more angry at Nxstage for this. They really poisoned her.

[caregivertech1]

Also agree. We spent several months in the teens (down from mid 20's) before the sub 10 numbers. Remember also we went back in-center on 2 separate 4 week periods trying to remove the aluminum and never got it below 12. It's tough to eliminate.

[Simon Dog]

The Fresenius clinic I use does an AL level check one a year, with the January monthly labs.

I'm on NxStage and haven't done a run with bags in months (currently using SAK 307)   My AL just came in at 5.

[Maggie and Jeff]

Maggie's AL went up to 10 over a year before the recall then spiked at 18 after the recall. 

Maggie switched to hanging bags when the recall started.

Her aluminum was 9 last month and 8 this month.

We are still using hanging bags.

[Hemodoc]

Sadly, after nearly a year of telling us after the recall, everything is fine, six months after telling the units that they have a new sodium lactate supplier, it still goes on Judah. (Ben Hur fans understand)

I went for my monthly visit today. I have been on the bags since July.mmy latest level is less than5. However, other patients seen in our unit and one with some of the same nurses have levels of 5-10. NxStage claims its is over, but it isn't. They still have low level poisoning. Stay away from the PureFlow. Even low levels of aluminim have chronic effects,