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CORDIS - EU research results
CORDIS

Clinical validation of a continuous flow peritoneal dialysis system, with dialysate regeneration

Project description

Renal dialysis at home

Kidney failure is treated with renal dialysis, a process that filters and purifies the blood from waste products and excess fluid. Conventionally it takes place in a healthcare setting using a dialysis machine. The key objective of the EU-funded CORDIAL project is to clinically validate a new peritoneal dialysis (PD) system that is portable and can be used at home or at work. It continuously circulates and regenerates dialysate in the peritoneal cavity achieving an improved blood purification in comparison to conventional devices. Moreover, it does not require high glucose concentrations that damage the peritoneal membrane. CORDIAL will test this novel PD system in patients at home and compare it with devices currently in the market.

Objective

Goal is the clinical validation of a new peritoneal dialysis (PD) system called CORDIAL. Instead of a stagnant filling as in traditional PD, CORDIAL continuously circulates and regenerates dialysate in the peritoneal cavity. Hereby, a significant improvement in blood purification (2-3x) can be achieved in comparison to traditional PD. For the regeneration, a sorbent unit is used to remove toxins from the peritoneal dialysate by adsorption. The sorbent system also facilitates slow release of glucose needed for osmotic removal of excess fluid (i.e. ultrafiltration). Very high glucose concentrations, as used in traditional PD and harmful to the peritoneal membrane, are no longer required, which helps to preserve the membrane function. CORDIAL is an easy to use, portable/wearable machine that allows renal patients to dialyze conveniently at home or at work, independently from a fixed water supply, up to 24 h/day. With the improved clearance and low glucose load, CORDIAL eliminates current drawbacks of PD (low efficacy, high glucose concentrations leading to damage to the peritoneal membrane), benefiting the overall health condition and quality of life (fitness, lower pill burden).
In order to demonstrate clinical efficacy and safety of the system an early feasibility first-in-human (FIH) trial will be performed in PD patients. The FIH study will involve a group of 12 stable PD patients who will be treated for 6 days with the new PD system spread over two weeks (3 consecutive days per week), which will be compared with baseline measurements in the week prior and after CORDIAL treatment. In addition, an advanced computational model will be developed and validated for CORDIAL using the FIH data, which can be used to conduct virtual human trials for rapid optimization of device settings/ design and personalization of the treatment.

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Topic(s)

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RIA - Research and Innovation action

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Call for proposal

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(opens in new window) H2020-SC1-BHC-2018-2020

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Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 153 998,56
Address
HEIDELBERGLAAN 100
3584 CX Utrecht
Netherlands

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Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 153 998,56

Participants (6)

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