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Method and device for measuring concentration of hardly diffusible uremic retention solutes in a biological fluid and for monitoring removal of said substances during dialysis by UV-absorbance (TOEE20160714001)


 ESTONIA

Technology collaboration OFFER
Created: 06/12/2016
Last updated: 15/01/2018
Fecha límite: 20/06/2018

Resumen

A new technique is on offer, suitable for monitoring small water-soluble molecules, as well as representatives from the higher molecular weight group of uremic toxins, so called middle-molecules, (MM). The real time continuous, on-line measurement of spent dialysate can help guide dialysis prescriptions by nephrologists and help dialysis staff to achieve treatment goals. Both industry and academia are sought for research, license, commercial agreements with technical assistance.


Partnership(s) sought

  • License agreement Commercial agreement with technical assistance Research cooperation agreement

Descripción completa

There is a lack of dialysis dose parameters beyond urea. New convective dialysis technology (e.g. HDF) aimed to increase the removal MM are more regularly used at dialysis units and new published studies confirm evidence that this mode of dialysis has advantages over traditional HD. Moreover, in recent years HDF has become more or less standard treatment especially in Europe. Since urea certainly is not a representative for all removed solutes, and is known to be rather non-toxic, an optical monitoring technique that is suitable for MM removal could be a valuable complement to urea based dialysis dose parameters.

Recently a dialysis dose equation for ß2-m has been developed utilising pre- and post- dialysis blood ß2-m concentrations (C0 and Ct).

For determination of the dialysis dose for ß2-m from the optical method, instead of the pre- and post-dialysis blood ß2-m concentrations, the UV-absorbance value in the beginning, A0 and at the end of dialysis, At, were utilized. The wavelength which yielded the strongest correlation between ß2-m concentrations measured in the spent dialysate by the new method (UV absorbance, 314 nm) and at the laboratory was used. This wavelength correlation maximum at 314 nm can then be used in an online performance later.

In dialysis units today urea is still the surrogate marker for dialysis efficiency despite that no improvement on patient outcome is seen if urea removal is greater than the treatment goals of today. Representatives from other molecule groups, i.e. MM and protein bound molecules (PBM) is not evaluated as routine in clinics at all, probably because there is no consensus what uremic toxins to be measured and that the analysis costs for these are very high.

The application field of the technique is preferably all types of HD including homeHD (patients treat themselves at home). The optical technique can be built into the future of dialysis machines or be used as a stand-alone tool, presenting information on a screen and saved in a data base. This new technology could be a valuable tool for achieving treatment targets, and also encouraging from a patient safety view.

Today, a common sampling plan for urea in the blood (urea removal during dialysis utilizing pre-and post-dialysis urea concentration), to verify patients' dialysis dose, occurs every eight weeks. This means that only 3-4 % of patients at least 156 treatments in a year will be evaluated. With this new optical technique every treatment can be evaluated not only in terms of urea removal but also removal of other representatives from other molecule groups which is known to have a greater impact of the high morbidity and mortality in this population.

The main innovative aspect with this work is the idea of estimate removal rate of MM utilising optical online measurements in spent dialysate during dialysis.

The novelty can be summarized as follows:

1) Real time evaluation of the dialysis process online by monitoring MM, simultaneously with SM

2) Meet and assess new dialysis technology aimed to improve MM removal

3) Possibility to individualise dialysis in terms of hardly diffusible uremic retention solutes

4) Save this type of information in a database for long-term evaluation both individually and in group level and start to set treatment goals for MM removal.

The research group is looking for R&D cooperation with biomedical companies and universities, to develop the method further (include additional compounds, application of the method on other biological fluids, more specific algorithms etc), licencing agreements and commercial cooperation with technical assistance, in order to develop a solution suitable for commercialization.


Socio buscado:

- Specific area of activity of the partner: We are looking for the following types of partnership:
- Providers of technology solutions for biomedical technologies, to to jointly develop the solution so that it could be commercialized.
- Licence agreements
- Research cooperation with biomedical companies and universities, to experiment with additional compounds, develop more specific algorithms, apply the methods on other biological fluids (i.e. blood serum or urine), customer-oriented development etc.


Advantages & innovations:

This is the first technology to monitor all different sized uremic toxins, whereas competitors focus mainly on urea. The high sampling frequency of the optical technique allows an immediate identification of any deviations in dialysis treatment and feedback after adjustments that have an impact on the clearance process, which is not possible with other technologies.

In the medical literature the uremic toxins are divided into three groups: 1) small molecules (MW < 500 Da); 2) middle molecules (MW > 500 Da); 3) protein-bound solutes. Different uremic toxins have effect to the patient by many different ways and extent, and to ensure the best survival, quality of the treatment and the quality of life for the dialysis patients monitoring of several uremic toxins is essential. Since urea is not representative for all removed solutes and is not toxic, an optical monitoring technique suitable for other uremic retention solute removal could be a complement to urea based dialysis dose parameters. Nowdays, due to availability of highly convective dialysis therapies like HemoDiaFiltration (HDF) which target to remove more efficiently the middle molecules (MM) (MW > 500 g/mol), the quality should be assessed by a marker molecule which belongs into MM uremic toxin group (e.g. ß2-m), or behaves like MM as can be expected by several protein bounded uremic toxins. Reduction of the accumulation and lower long-term levels of these compounds may prevent or delay the appearance of such complications and mortality.


Development Stage:

Under development/lab tested - solid research background, well-specified field of application


IPR:

Patents granted

Clasificado como: Medicine and Health \ Ciencias de la vida


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