End-stage renal disease, ESRD
Conditions
Interventions
Group 1: The ShuntMerlin study is a multicenter, non-interventional observational study investigating the correlation between smartphone-based audio recordings of dialysis shunts and sonographic findi
Sponsors
Universitätsklinikum Augsburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Legally competent patients who have been informed about the study in written and oral form and have provided informed consent to participate. Women and men over 18 years of age with a native forearm arteriovenous shunt (so-called Cimino fistula/radiocephalic AV fistula), either left- or right-sided.
Exclusion criteria
Exclusion criteria: Patients with prosthetic shunts (e.g., PTFE grafts, AngioSeal®, Goretex®). Patients with left ventricular assist devices (LVADs). Patients with severe valvular heart disease. Dependent patients under care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Detection of shunt dysfunction What: Detection of a clinically relevant shunt dysfunction (stenosis, reduced blood flow, or thrombosis), confirmed by ultrasound (gold standard). When: Continuously throughout the study; event-driven at the time of clinical diagnosis or required intervention, as well as at predefined follow-up time points or during dialysis sessions. How: Smartphone audio recordings of the shunt (10–30 s, once weekly, using a standardized app and measurement site) with AI-based analysis; comparison with clinical routine diagnostics (duplex ultrasound, possibly angiography) and documentation by the vascular medicine/nephrology team. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: -Patient-Reported Outcomes (PROs) What: Patient satisfaction and perceived safety in managing the vascular access (shunt) and the monitoring system. How measured: Using validated questionnaires (PHQ-9 and WHOQOL-100), as well as additional items assessing perceived safety, usability, and satisfaction with the smartphone-based shunt monitoring system. -Adherence to measurements What: Reliability of patients in performing the smartphone-based shunt recordings. How measured: Proportion of completed recordings compared to scheduled recordings, based on app log data (timestamps, completeness of recordings). | — |
Countries
Germany
Contacts
Public ContactAlexander Hyhlik-Dürr
Universitätsklinikum Augsburg
Outcome results
None listed