Indicators of Safety and Wellbeing in Patients Starting Maintenance Haemodialysis Using Phased Approach: Findings from a Cohort Feasibility Study

Background: The optimal method of starting maintenance haemodialysis (HD) in patients with kidney failure is not known. We have compared early treatment characteristics, blood pressure trajectories, and selected dialysis-related safety events in patients who started HD using a stepped and phased approach, with those who received conventional care. Method: A single-centre cohort feasibility study was conducted. Participants with kidney failure, about to start maintenance HD, were enrolled prospectively (intervention arm). They started treatment on a novel regime comprising four pre-specified incremental steps (Phases 1 to 4) over 14 weeks. They were matched using propensity scores with historical controls: patients who had previously started HD on a three-times weekly basis from the outset (control arm). Results: The final cohort comprised 15 and 29 participants in the intervention and control arms respectively (1:2 ratio; one control excluded after matching). Intervention group participants were slightly older with a higher proportion of men. The rate of decline in blood pressure was slower in the intervention group. There were also signals for fewer events of intra-dialytic hypotension (211 vs. 379 per 100 person-year), infections not requiring admission (56 vs. 114 per 100 person-year) and loss of vascular access (56 vs. 79 per 100 person-year) in intervention group. There was a signal for higher incidence of severe hypertension (systolic BP ≥ 180 or diastolic BP ≥ 110 mmHg) in the intervention group. Hospitalisation rates were similar; there were no deaths and one non-fatal major cardiac event (MACE) in the intervention group, and one death and no MACE in the control group. Conclusions: Implementing a short transitional regime of incremental HD may be possible in clinical settings, potentially helping to reduce the gradient of physiological change and burden of early treatment. The findings of this feasibility study are exploratory, and fully powered randomised controlled trials are needed to establish the efficacy and safety of such a programme.