Real-time renal diagnostic to prevent ICU-acquired Acute Kidney Injury (AKI) - Clarity

Programme(s):
H2020-EU.3. - PRIORITY 'Societal challenges
H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs
H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies

Topic(s): EIC-SMEInst-2018-2020 - SME instrument

Call for proposal: H2020-SMEInst-2018-2020-1

Funding Scheme: SME-1 - SME instrument phase 1

Grant agreement ID: 882261

Project description
Novel renal diagnostic tool to prevent acute kidney injury
According to the statistics, each year around 1.7 million people worldwide die from acute kidney injury (AKI), which in many cases develops during intensive care unit treatment. The best treatment for this complication is timely prevention. The EU-funded Clarity project introduces a critical care monitoring system that uses patented sensor technology, which enables analyses of the continuously changing composition and flow volume of urine, informing the medical staff in real time about changes in these parameters on a continuous basis. This information reflects changes in renal function and provides an early sign of AKI risk with the purpose of facilitating immediate intervention. The system has been tested during initial clinical trials and is currently being prepared for large-scale clinical trials.

Objective
Intensive Care Unit (ICU)-acquired Acute Kidney Injury (AKI) is a prevalent and serious problem, associated with significantly increased morbidity and mortality. According to the Global Burden of Disease (GBD), each year around 1.7 million people worldwide are estimated to die from AKI. AKI develops in over 57% of ICU patients, requiring an average of 3.5 additional hospital days and €13,000 of additional hospital costs per patient. The best treatment for AKI is prevention. Although there is no curative therapy for AKI, research over the past decade identified various means to prevent or limit AKI. Unfortunately, these are not widely known and are variably practiced worldwide resulting in lost opportunities to improve the care and outcomes of patients with AKI.
RenalSense introduces Clarity RMS™, a critical care monitoring system that continuously measures urine flow, automatically transmitting to the medical staff real-time data and alerts of fluctuations, on a 24/7 basis. Using patented sensor technology, Clarity measures, analyses and interprets the continuously changing composition and flow volume of urine. This information, which reflects changes in renal function, provides an early sign of AKI risk and facilitates rapid intervention. In addition, it is invaluable for monitoring treatment efficacy and managing fluid balance. The system has been tested during clinical trials with Herzog hospital, Hadassah Medical Organisation and University of Pittsburgh. Analysis of 1,000 study hours showed that electronic measurements with Clarity were more consistent, reliable and accurate than nursing records.
During the feasibility assessment, RenalSense will establish a go-to-market strategy, as well as a feasible product development plan and industrialization strategy. The plan for the large-scale clinical trials will be defined, and the participants secured.