Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms (ICHARUS): Study Protocol for a Prospective,...

Persistent uremic symptoms remain common among patients receiving maintenance hemodialysis, even when contemporary dialysis prescriptions are optimized. These symptoms are only partially captured by conventional adequacy metrics and represent a major determinant of health-related quality of life. A growing body of evidence suggests that incomplete removal of protein-bound uremic toxins and larger middle molecules contributes to persistent symptom burden. Hemoadsorption, when integrated into the extracorporeal circuit, provides an additional clearance mechanism that may enhance solute removal beyond diffusion and convection alone. The ICHARUS study is a prospective, multicenter, observational, real-world registry enrolling adult patients receiving hemodialysis with persistent uremic symptoms despite optimized conventional therapy. Hemoadsorption combined with hemodialysis will be prescribed according to routine clinical practice. Study visits are scheduled at baseline and at one, three, and six months. The primary endpoint is the change in patient-reported symptom burden, assessed using the Dialysis Symptom Index, from baseline to three months. Secondary endpoints include changes in symptom-specific patient-reported outcomes, health-related quality of life, selected biochemical markers, and safety. By focusing on patient-reported outcomes in a pragmatic setting, the ICHARUS study aims to generate structured real-world evidence on the feasibility, safety, and potential clinical relevance of hemoadsorption combined with hemodialysis, supporting patient phenotyping and informing future hypothesis-driven interventional studies. ClinicalTrial.gov ID: NCT07522008.