INTRODUCTION In patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH) is a clinical problem that nephrologists and dialysis nurses face daily in their clinical routine . Despite the technological advances in the field of HD, the incidence of hypotensive events occurring during a standard dialytic treatment is still very high . Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term . Various strategies aimed at preventing IDH are currently available, but there is lack of conclusive data on more integrated approaches combining different interventions .
METHODS AND ANALYSIS This is a prospective, randomised, open-label, crossover trial (each subject will be used as his/her own control) that will be performed in two distinct phases, each of which is divided into several subphases . In the first phase, 27 HD sessions for each patient will be used, and will be aimed at the validation of a new ultrafiltration (UF) profile, designed with an ascending/descending shape, and a standard dialysate sodium concentration . In the second phase , 33 HD sessions for each patient will be used and will be aimed at evaluating the combination of different UF and sodium profiling strategies through individualised dialysate sodium concentration .
ETHICS AND DISSEMINATION The trial protocol has been reviewed and approved by the local Institutional Ethics Committee (Comitato Etico AVEN, prot . 43391 22.10.19). The results of the trial will be presented at local and international conferences and submitted for publication to a peer-reviewed journal .
TRIAL REGISTRATION NUMBER ClinicalTrials.gov Registry (NCT03949088).