Enabling Technology to Prepare Ultrapure Dialysate in Dialysis Clinics

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R44DK093307-01
Agency Tracking Number: R44DK093307
Amount: $2,299,998.00
Phase: Phase I
Program: SBIR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: NIDDK
Solicitation Number: PA10-050
Small Business Information
DUNS: 943652065
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (609) 683-0215
Business Contact
Phone: (609) 683-0215
Email: labib@novaflux.com
Research Institution
DESCRIPTION (provided by applicant): The clinical significance of chronic pro-inflammatory reactions in dialysis patients due to exposure to endotoxin has become a central issue in nephrology. The European Renal Association urges the routine use of ultrapure dialysate with bacteria and endotoxin levels of lt 0.1 CFU/ml and lt 0.03 EU/ml, respectively. In the US, the maximum allowable limit of bacteria in water is 200 cfu/ml and the maximum allowable limit for endotoxin is 2 EU/ml. Considering the clinicalimplications and risks of exposing dialysis patients to a high level of cytokine- inducing molecules on a continuous basis, the US needs to quickly move to adopt the ultrapure dialysate (UPD) ISO 1163:2009 Standard. However, considering the state of US dialysis water systems, meeting such standard will be impossible to achieve without adopting new technologies that can eradicate biofilm from the dialysis water systems and correcting some inherent deficiencies in current maintenance protocols. In this FastTrack application, we propose to develop an integrated strategy to produce UPD based on using our CleanFlow device which delivers the highly effective two-phase flow (TPF) process. This strategy must consider treating all the surfaces of the water systemto the point where the dialysate enters the dialyzer. In this project we will develop methods and protocols to test the integrated strategy in dialysis clinics. We will verify that we can reduce inflammation markers (IL-6 and CRP) in patients treated withdialysate made according to this new strategy. The integrated strategy will include: 1) cleaning the distribution loops with the TPF process, 2) replacing the connection tubing to dialysis machines with a cleaned and disinfected set each time, and 3) ensuring that dialysis machines are equipped with a retentive ultrafilter before the dialyzer. We will compare the results of our integrated strategy with conventional methods, and will assess the impact of using or not using the ultrafilter on the results. Weplan to also include testing for bacterial DNA fragments in the dialysate before and after the ultrafilter. Development of this integrated strategy to produce UPD in US dialysis clinics is expected to decrease the chronic inflammation state in dialysis patients and increase responsiveness to erythropoietin. PUBLIC HEALTH RELEVANCE: In this Fast Track application, we propose to develop an integrated strategy to produce ultrapure dialysate (UPD) based on our proven capability of effectively removing biofilm from dialysis water systems using the CleanFlow device which delivers the novel two-phase flow (TPF) process. The strategy and approach detailed in this application address the logistical issues that clinics must adhere to in order to be able to make UPD, including: 1) the use of a retentive ultrafilter before the dialyzer, and 2) changing the connection tubing to dialysis machines during each cleaning. The project is directed to developing the technology and protocols that will enable US clinics tomeet the ISO 1163:2009 standard for UPD. Success of this development will make it possible for clinics with PVC piping construction to meet the above ISO standard at a reasonable cost, and will translate into decreasing the level of inflammatory biomarkers in dialysis patients and into increasing responsiveness to erythropoietin.

* Information listed above is at the time of submission. *

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