Study on ultrapure dialysate and inflammatory repsonse

Discussions for Patients, Family, and Friends HD For Patients
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Nephrology Dialysis Services

© The Author [2006]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
Received July 20, 2005
Accepted May 8, 2006

Original Article

Ultrapure dialysate and inflammatory response in haemodialysis evaluated by darbepoetin requirements–a randomized study
José M. Lamas 1 *, Mario Alonso 1, Fernando Sastre 2, Gerardo García-Trío 1, Jesús Saavedra 1, and Luisa Palomares 2
1 Hospital Meixoeiro, Complejo Hospitalario Universitario de Vigo, Vigo, Pontevedra, Spain
2 Centro de Diálisis Os Carballos, Fundación Renal Iñigo Alvarez de Toledo, Nephrology, Vigo, Pontevedra, Spain

Abstract

Background. Dialysate quality has been suggested to influence inflammation status in patients subject to haemodialysis (HD). The aim of this study was to compare ultrapure dialysate (UPD) vs conventional dialysate (CD) with respect to darbepoetin requirements and other inflammation markers.

Methods. A controlled prospective randomized study was carried out on 78 patients from two HD units who were treated with low-flux polyamide dialysers. Patients were assigned to two groups by using different sized blocks per unit and dialysis session. One group received CD treatment while the other was treated with UPD over 12 months. From the groups, 37 patients started treatment with CD and 41 with UPD while 31 patients ended with CD and 30 with UPD. The main variables analysed were haemoglobin (Hb) and darbepoetin dose; other variables studied were C-reactive protein (CRP), albumin, interleukin-6 (IL-6) and interleukin-1 receptor antagonist (IL-1Ra).

Results. No significant differences were observed between the two groups for the variables analysed. At the beginning of the study the following values of CD and UPD were assesed: Hb 11.3 and 11.3 (g/dl); darbepoetin dose: 0.49 and 0.44 (µg/kg/week); CRP: 13 and 24 (mg/l); albumin: 3.8 and 3.7 (g/dl); IL-6: 5.94 and 4.18; and IL-1Ra: 345 and 420 (ng/l), respectively. At the end of the study the values of CD and UPD were: Hb 12 and 11.9 (g/dl); darbepoetin dose: 0.47 and 0.48 (µg/kg/week); CRP: 14 and 14 (mg/l); albumin: 3.8 and 3.7 (g/dl); IL-6: 14.03 and 12.93 and IL-1Ra: 322 and 340 (ng/l).

Conclusions. UPD does not improve the inflammatory status evaluated by darbepoetin requirements in conventional HD patients treated with low-flux polyamide dialyser. Further controlled studies are required to evaluate the clinical influence of UPD in HD with other low- and high-flux membranes.

Keywords: C-reactive protein; darbepoetin; endotoxins; haemodialysis; haemoglobin; inflammation; interleukin; ultrapure dialysate.

Online ISSN 1460-2385 - Print ISSN 0931-0509 Copyright © 2005 European Renal Association - European Dialysis and Transplant Assoc

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Jane what’s with the cut and paste jobs? It’s a good thing to share studies that you find interesting or confounding but provide some context. Write a line or two that introduces the study, say what it is about this study that you think merits discussion. Why post an abstract and not even add a single comment?

Also if you would sign up with Home Dialysis Central as an official registered user you could edit your posts and remove all of the PubMed debris. This study is saying that when combined with low-flux polyamide dialysers ultra pure dialysate showed little effect. Umm, okay but who’s using low-flux polyamide dialysers? Are you?

The other study seems to confirm that dialyzors who shoot up with anabolic steroids may increase their muscle mass. Umm, okay.

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I spoke to my Doctor a few weeks ago about inflamation and the current tech in use right now and what he stated is that there’s no definite proof or answers, its all research, speculations…

He stated that some patients have high c-reactive(inflamation) regardless what method of dialysis they were doing. It has to do alot with illness…if some patients have alot of health problems their reactive-c is high! In my example, my reacive-c c is tinsy tiny low! :stuck_out_tongue: …so I feel quite glad its not on danger zone at all!

That article Jane posted gives a hint that perhaps dialysate has nothing to do with inflamation, BUT am not saying that article is a fact but just their speculation.

However, there is a BIG difference between Ultra-Pure and Standard dialysate. physcially they both have their Pros and Cons and for the most part I think Ultra-Pure does a better job than standard…the more pure the dialysate the less prone to reactions during dialysis…

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Because there is naturally going to be more backfiltration overall during an 8 hour treatment (note my use of the term “backfiltration” this time, as I was corrected by Bill earlier), the program here does use “ultrapure” dialysate already.
Pierre

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Bill:

Jane what’s with the cut and paste jobs? It’s a good thing to share studies that you find interesting or confounding but provide some context. Write a line or two that introduces the study, say what it is about this study that you think merits discussion. Why post an abstract and not even add a single comment?

Abstracts I share are self-explanatory. One can choose to comment or not. I don’t have the inclination to do all you suggest although agree it would be nice if I had the time and knowledge on the subject to discuss. Usually when I share an article I am looking for education from those who have an opinion on the subject.

Bill:

Also if you would sign up with Home Dialysis Central as an official registered user you could edit your posts and remove all of the PubMed debris

Ok sure next chance I get.

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Jane & Bill, I edited out the extra PubMed stuff. The way I copy and paste PubMed articles into the message boards is by sending the abstract to text (option beside where it says “Display”). Below I have included an abstract from Taiwan that I sent to text and removed the extra spaces because the line length is shorter on PubMed than on this message board. I’d trust this abstract more than the other because it used the research methodology that is the “gold standard” of research – a “randomized controlled clinical trial” (RCCT). The study looked at the same patients over time. One group used ultrapure dialysate for 6 months while the other used conventional dialysate. After 6 months, the group switched dialysate. This study found significant improvement in C-reactive protein (CRP) levels and better anemia management with less EPO and iron when patients used ultrapure vs. conventional dialysate.

J Nephrol. 2004 Sep-Oct;17(5):693-700.

Ultrapure dialysate improves iron utilization and erythropoietin response in chronic hemodialysis patients - a prospective cross-over study.

Hsu PY, Lin CL, Yu CC, Chien CC, Hsiau TG, Sun TH, Huang LM, Yang CW.

Department of Nephrology, Chang Gung Memorial Hospital, Taipei, Taiwan.

BACKGROUND: The impact of ultrapure dialysis on dialysate-related chronic inflammatory status and anemia in uremic patients on maintenance hemodialysis (HD) remains uncertain. We evaluated ultrapure dialysate effects on erythropoietin (EPO) response and inflammatory status in a prospective, randomized, cross-over study. METHODS: Thirty-four HD patients were divided into two groups. One group was treated with conventional dialysate and the other group with ultrapure dialysate for 6 months and crossed over for another 6 months. Bacteria growth and dialysate endotoxin were examined. Parameters including C-reactive protein (CRP), recombinant human erythropoietin (rHuEPO) dose, ferritin, iron saturation and serum albumin were measured at the start, and at 6 and 12 months. RESULTS: The endotoxin levels reduced significantly in the ultrapure dialysate by adding a dialysate ultrafilter. After a 6-month treatment with ultrapure dialysate, there were statistically significant differences in the systemic inflammation markers between both groups. Changing from conventional to ultrapure dialysis fluid significantly reduced CRP (7.01 +/- 5.059 to 4.461 +/- 3.754 mg/L, p<0.05), and resulted in reduced rHuEPO doses (12500 +/- 7060 to 10440 +/- 7050 U/month, p<0>0.05). The ferritin level reduced significantly (422 +/- 183 to 272 +/- 162 mcg/L, p<0.05) in the ultrapure dialysate group. After another 6-month cross-over, the study parameters were reversed among the two groups indicating the beneficial effect of ultrapure dialysis. CONCLUSIONS: Through endotoxin reduction in conventional dialysate, ultrapure dialysis in dialysis patients manifested a reduced inflammatory parameter, reduced rHuEPO dose and improved iron utilization; and therefore, could be beneficial in anemia treatment.
Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 15593037 [PubMed - indexed for MEDLINE]

So what does it mean…controlling anemia with less EPO and iron saves money for patients, clinics, and payers. Reducing CRP levels may help save people from strokes and heart attacks. Here’s info from the American Heart Association about the link between CRP and stroke and heart disease/heart attacks.
http://www.americanheart.org/presenter.jhtml?identifier=4648

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Isn’t this subject becoming merely academic anyway? I’ll bet that most people on home hemo are already getting dialysate which meets ultrapure standards.
Pierre

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I’d like to believe that but don’t know it for sure. Fresenius now has ultrapure dialysate. Aksys has always had ultrapure dialysate. NxStage has sterile dialysate. I don’t know about all the other dialysis machines on the market in the U.S. and elsewhere. I know that many in-center patients don’t have dialysis with ultrapure dialysate.

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Can bacteria grow in UltraPure? What about sterile? How do they make Sterile? UltraPure===>Sterile ? :roll:

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In the study high flux polysulfone dialyzers weren’t evaluated ( with Ultrapure (which is a FMC brandname?) Most, if not all pts. are using high flux dialyzers so perhaps this “study” is outdated. Too, does anyone know what the definition of ultrapure actually is? Is it JUST a name which by the way shares the name FMC has for their dialysis program, Ultra? The first unit I was at was an FMC unit; Dialysis Dave the dummie who watched over the scale (a cardboard figure so no one thinks me ill mannered :lol: ) was part of the launch of Ultracare; it made no difference for better or worse. Lin.

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Ultrapure is not a Fresenius brand name. It’s actually a designation of the quality of water used in dialysis. Fresenius uses the term “Ultracare” to describe its services, including the fact that its dialysate meets the level of water quality to be called ultrapure.

Here’s an article that is posted on the Home Dialysis Central website that describes what conventional water can have so far as bacteria and endotoxins (toxins left behind when bacteria are killed) and what ultrapure water can have and still be called ultrapure.
http://www.homedialysis.org/v1/rotating/0905topicofthemonth.shtml

Sterile solution must have even less bacteria and endotoxins or it can’t be called sterile. Here’s how NxStage describes its sterile solution:

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Additional information at…


On-line Preparation of Solutions for Dialysis!

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Another good link which explains how and why water must meet stringent standards. Someone once asked about if home hemo might avoid Amyloidosis, and that too is mentioned. Supposedly using Ultrapure dialysite will curb it.

http://www.medicalairsolutions.com/techref/cdc/hicpac_2001_water.htm#Dialysis

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Lin.,
Filed your article for when I get a chance to read. Notice it contained info on contamination in ice machines. Think you said your husband works for a water dept., so maybe you understand this subject a little better than most. Saw a news report recently about ppl who became sick due to contaminated ice machines at a number of the fast food restaurants. Of course, the ff places were not following the infection control regulations and got right on it once their reputation was on the line.

I don’t know how the ff restaurants and regular restaurants are where other folks live, but where I have lived, and I have lived in different parts of the country, they are getting so dirty and disgusting, I can’t stand to hardly even go out for a burger anymore. I have noticed that the cashiers handle food with the same hands money is handled with, and if you look back into the food prep area, it is dirty, and food is all over the floor. The dining area is disgusting, too, at so many places. There seems to be a problem with restaurant inspections just as there is in healthcare.

As you know, I am appauled by the lack of infection control in units. My last unit had nice pictures on the wall, but was still a dirty place. They gave us nice treats like ice tea and snow balls. One day it occured to me that if the unit itself was not clean, I wonder what the ice machine is like, so I took a look when no one was around. Just as I thought- it had mold and mildew growing in it ugh! Even if one could get a copy of the water report for the water system, who knows if they really follow protocol.

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We really are safer at home, even though admittedly my house is not spic and span, partly because it’s small and I share it with three pets. We tend to become resistant to our everyday environment, plus we’re not exposed to a lot of sick people :wink: Home hemo will keep us exposed only to an environment that hopefully we have built up resistance to. I don’t eat out much, but do notice the things you do. In the grand scheme of things there are other things in my life that are way more important, like just trying to get house clean and laundry kept up at same time, that and I don’t have to eat out. Husband has both small and industrial waste water licenses, and qualifies for potable water license but is such a busy guy can’t find time to take the test, because it is just his part time job. In engineering by day. Lin.