Descripción del proyecto
Diálisis renal en casa
La insuficiencia renal se trata con diálisis renal, un proceso que filtra purifica la sangre de productos residuales y del exceso de fluido. Tradicionalmente, se realiza en un centro de atención sanitaria con una máquina de diálisis. El objetivo principal del proyecto CORDIAL, financiado con fondos europeos, es validar clínicamente un nuevo sistema de diálisis peritoneal (DP) portátil que puede utilizarse en casa o en el trabajo. Circula continuamente y regenera el dializado en la cavidad peritoneal, por lo que logra una mayor purificación de la sangre que los dispositivos convencionales. Además, no requiere concentraciones elevadas de glucosa, que dañan la membrana peritoneal. CORDIAL probará este novedoso sistema de DP con pacientes en casa y lo comparará con los dispositivos que ya están en el mercado.
Objetivo
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 and a crossover feasibility 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. Upon successful functionality and safety analysis of the FIH trial, the clinical validation is continued in a crossover study to test the hypotheses that the system (1) improves blood purification, (2) results in adequate ultrafiltration at low glucose concentrations and (3) does not show important safety/ biocompatibility problems. Hereto 30 stable PD patients will be randomized to receive at home either CORDIAL treatment in the first 2 months and traditional PD in the month 3 and 4 or vice versa.
Ámbito científico
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SC1-2020-Two-Stage-RTD
Régimen de financiación
RIA - Research and Innovation actionCoordinador
3584 CX Utrecht
Países Bajos