online-hdf the superior quality of treatment thomas ryzlewicz
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online-HDFthe superior quality of treatment
Thomas Ryzlewicz
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axle of the cart of Ben Hur multi-link rear suspension of BMW
. . . comparable to High-Flux HD . . . comparable to online-HDF
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High-Flux HD?
HEMO study5000 pat.
MPO study5000 pat.
Low-Flux : High-Flux
NO better survival for High-Flux(!)
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online-Therapy
1982 S. Shaldon: Interleukin-1-Hypothesis 1983 S. Shaldon: on-line-Hämofiltration as
(Prototyp): two-step procedure, 20 Ultra-Filters(!)
6/1993 first on-line-Monitor of today in Germany (in reality: in-line)
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3 advatages of online-HDF
1. sterile Dialysis Fluid
2. additional secondary big Clearance
3. additional elimination of big molecules (ß2M, up to 40 kD)
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Low-flux-HD High-flux-HD online-HDF
pressures in the Dialyzer
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Low-flux-HD High-flux-HD online-HDF
pressures in the Dialyzer
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hydraulics at Highflux-HD
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hydraulics at online-HDF
solvent dragconcentratin
gradientinfusion port
predilution
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online-Therapy is the production of Infusion Fluid!
CFU’s in the Dialysis Fluid:how much is little?
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online-Therapy is the production of Infusion Fluid!
European Pharmacopoeia 2005 did not know online-production of Infusion Fluid(!)
Infusion Fluid must be sterile
ISO-Norm 11663-2014 quality of Dialysis Fluid and related Therapies (sterile and free of pyrogen (=>EU<0,03/ml))
SAL > 6 (sterility assurance level)
corresponds
10-8 CFU reduc./ml 3 Filtre (ultra) 10-11/ml
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online-Therapy is the production of Infusion Fluid!
tap-water Dialysiswater
Standard
HD-Fluidultrapure Dialysis Fluid
sterile & pyrogen-free Infusion Fluid
Softener & Reverse-Osmosis
Conzentrats Ultrafiltration Ultrafiltration
bakteriolog. Qualität
CFU/ml
EU/ml
Use in the Dialysis
< 10-2
< 0,25
< 102
< 0,50
< 10-3
< 0,03
SAL* > 6
< 0,03
Basics for every Dialysis Fluid
Lowflux synthetic
Highflux-HD & Low.-Vol.-HDF
online-HDF/HF Infusion Fluid
according to I. Ledebo
ISO-Norm 11663-2014
SAL* = sterility assurance level
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online-Therapy is the production of Infusion Fluid!
the Ultra concept:
one step Ultrafiltration CFU reduction of 10-5 SAL 3
two step Ultrafiltration CFU reduction of 10-8 SAL 6
three step Ultrafiltration(with U-2000-Filter)
CFU reduction of 10-11 SAL 9
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online-Therapy is the production of Infusion Fluid!
1. Disinfektion with Peracetic Acid (Dialox)2. Monitor should not used for online-Therapy, if there
was no qualified Disinfection3. Test for chemical residue must be done4. Bacteriology from the Infusion-Port before the
exchange of the Ultrafilters (U 8000 S) every 8 weeks
therefore:
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how does a HDF-Regime look like?
Qb = 400 cc/min.
Qd = 500 cc/min.,
of this 400 cc/min. diffusive
and 100 cc/min. convective
Infusate 6,0 Ltr./h.
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HDF-Regime in numbers
largest Highflux high Blood Flow (preferably 15 G cannulas) operation in Volume mode / Predilution Filtration 6,0 Ltr./h., this means 27 Ltr. in 4:30 h
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HDF: Predilution or Postdilution?
Predilution Postdilution?
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HDF: Predilution oder Postdilution?
disadvantage: reduction of the concentration gradient
disadvantage: lengthening of the way of Diffusion by the packed RBC‘s
disadvantage: development of a clear secundary membrane
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online-Hemofiltration
PredilutionQb = 400 cc/min.tubule 15 G
HF 1967 Lee Henderson as Predilution
PostdilutionQb = 700 cc/min.tubule 14 G
shifted to Postdilution because of costs
but in online-therapy costs are not the problem!
(I. Ledebo 1993)
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Predilution or Postdilution?
4:30 h Predilution 27 Ltr. 4:30 h Postdilution 27 Ltr.9 years treatment time, body weight both ~ 55 kg
reached 40 years RRT after 31 years RRT
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online-HDF Studies
B. Canaud 2004 retrospective indication for longer survival
F. Maduell 2012 prospectiveproven longer survival
CONTRAST 2012 prospectiveno longer survival
E. Ok 2013 prospectiveno longer survival
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Kaplan–Meier curves for 36-month survival in the intention-to-treat population (P=0.01 by the log-rank test).
Francisco Maduell et al. JASN doi:10.1681/ASN.2012080875
©2013 by American Society of Nephrology
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how many liters of exchange?
Ok 17 l Maduell 20,8 – 21,8 l
Postdilution Postdilution
Volume Mode Autoprocessing
no better survival proven longer survival
Blankestijn 19,8 l
Postdilution
Autoprocessing
no better survival
Turkish CONTRAST ESHOL
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Problems of these 3 studies
all the three:treatment time too short
blood flowtoo low
additional Ok study:Postdilutionwithout
Autoprocessing
Advatages of Predilution not used (> higher convective exchange with lower requirement of blood flow(!))
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Difficulties & Problems of online-Therapy
Postdilution the wrong dicision of the Industry, escape: Autoprocessing
2-step Ultrafiltration done later on, ISO Norm 11663(!), CFU controlling!
Disinfection the Disinfection: the concept should not weakened by the mode of Disinfection!
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Improvement for online-HDF?
Qualified Therapy:2 m² High-FluxPostdilution 6 ltr/h(= 100 cc/min.)
Autoprocessing(easy to handle with High-Tech-Monitor)
Improved Therapy:2 m² High-FluxPredilution 7,5 or 9,0 ltr/h (= 125 or150 cc/min.)Volume Mode(Standard Monitor,not-well-understood)
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Prime : Option
High-Flux HD:short treatment timeno interests for Kt/Vno interests for
clean fluidre-use
online-HDF:intention for longer patient‘s survivalrealized efficacy
also with longer treatment time
clean fluid realizedno re-use
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Points of discussion for the FDA?door-opening by Blankestijn?
2-step Ultrafiltration
realizing ISO norm 11663-2014with bacteriologic samplingand an effective Disinfection(!)
documentation of processed Infusion and Kt/V
additional payment only, whenquality parameters are fullfilled
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So the US Ministry of Health is kindly asked . . .
to make the FDA Dep. Med. Products working
or to renew the FDA-BOARD!