The d-LIVER project is application-orientated and based on four inter-linked scenarios, defined by clinicians, which drive ICT and sensor technology development in order to meet exactly the needs for continuous clinical support, monitoring and therapy of liver patients at the point of need from hospital to home settings. These scenarios are:
1. Chronic liver failure
The following aims have been defined for this patient population:
- Effectively treat acute-on-chronic liver failure
- Reduce intermittent encephalopathy
- Enable long-term therapy in the home environment
The acute-on-chronic liver failure scenario will be the platform for the clinical evaluation of the d-LIVER bio-artificial liver support system both in the hospital and in the home.
2. Chronic cholestatic itch
This scenario will deal with the intermittent long-term therapy of cholestatic liver disease in association with chronic itch. Reducing cholestatic itch can have a major impact on the quality-of-life and the ability to work. Patients with resistant cholestatic itch can often require transplantation despite having preserved liver function. The d-LIVER platform will extend the time before transplantation becomes inevitable and will allow those patients a greater degree of activity.
3. Bridging therapy before liver transplantation
The aim of this scenario will be the provision of effective bridging therapy for high-risk patients in their home environment. The goal will be a reduction in the duration and incidence of pre-transplant hospitalization, thus reducing waiting-list mortality given the clear association between hospitalization pre-transplant and poor outcomes.
4. Acute liver failure
This scenario is important for several components of the Liver Patient Management System (LPMS): the evaluation of the disease severity and the d-LIVER support system. Acute liver failure scenarios could include acute parenchymal liver injury, “small for size” syndrome where the remaining liver left after a liver resection for liver cancer proves insufficient to give adequate liver function or very indolent acute liver failure (e.g. drug-induced liver failure which can develop very slowly).
Figure: Patient pathways in the LPMS dependent on clinical condition
On the basis of these scenarios, a full set of both physical and biochemical parameters have been defined in d‑LIVER which will be required to be measured either at regular intervals (patient status monitoring) or continuously (BAL efficacy monitoring). Each scenario has its own most appropriate sub-set of these essential parameters which will be required to be measured and communicated with the ICT LPMS. The pathway for liver patient inclusion in d‑LIVER and the subsequent resulting therapy, monitoring and support scheme is shown in the figure above.
Monitoring will fundamentally focus on five main branches:
- Indication/ decision/ timing/ planning for bio-artificial liver support sessions
- Basic remote monitoring during d-LIVER bio-artificial liver support therapy
- Evaluation of therapy success after liver support / detoxification
- Remote monitoring of patient liver function/ toxin level/ general condition until the indication for the next session
- Actual recommendations for patients at home regarding personal life-style and behaviour based on patient data monitored by the LPMS