P1083A TRANSITIONAL REGIME OF INCREMENTAL HAEMODIALYSIS IN PATIENTS WITH END-STAGE RENAL DISEASE (ENDURE): A FEASIBILITY TRIAL
Authors: Hazara Adil , Allgar Victoria , Bhandari Sunil 
Published: June 2020

Background and Aims

Mortality rates are high in patients starting long-term haemodialysis (HD) therapy, particularly in the first 6-months. Incremental HD has been proposed as a means of making patients’ transition into long-term HD treatment less physiologically demanding with reduced burden of treatment at the start. A feasibility study is being conducted with the primary aim of evaluating the acceptability, tolerance and safety of a novel incremental HD regime. The secondary aims are to study the effect of incremental HD on residual renal function (RRF), fluid load, quality of life, functional status, blood pressure and blood markers of renal anaemia, secondary hyperparathyroidism and cardiac load.

Method

The regime being tested aims to start patients on twice-weekly HD with progressive increases in the duration and frequency of sessions over approximately 15 weeks (figure 1). 40 patients from pre-dialysis clinics, who have been referred for start of long-term HD therapy, will receive the study regime (incremental HD group). They will be followed-up for 12 months.

Acceptability and tolerance will be gauged by documenting rates of participation and retention in the study. Completion rate of each study test will be recorded to evaluate the feasibility of their inclusion in a future trial; these tests include: 24-hour urine collection to measure RRF, bio-impedance analysis for estimation of overhydration, six-minute walk test to monitor performance status and a quality-of-life questionnaire.

Rates of pre-defined safety events will be recorded and compared to a cohort of 40 matched patients who previously started conventional HD (historical controls, conventional HD group). Blood tests for estimation of RRF and markers of renal anaemia, bone disease and cardiac load will be performed at regular intervals and compared to the conventional HD group.

Results

Eight months in to the 18-month recruitment period, 106 patients have been screened for participation in the trial. Of these, 47 (43%) met eligibility criteria. Reasons for exclusions were: patient choosing other dialysis modalities over HD, 34; clinically unsuitable for incremental HD, 7; dialysis modality undetermined, 6; already started HD, 5; for conservative (non-dialysis) management, 4; non-compliant with treatment, 3.

Of the 47 eligible patients, 35 have been approached by the study team. Of these, 16 (46%) have been consented, 10 (28%) declined and 9 (26%) remain undecided. Patients who consented were relatively older compared to those who declined (68 vs. 58 years) and to all eligible patients (68 vs. 63 years). Men were more likely to decline than women (M:F ratio 1.3 vs 4.0 among participants and decliners respectively). Not all study participants have started treatment yet. Baseline characteristics of the first 6 patients starting incremental HD and their matched controls are shown in table 1.

Conclusion

The ENDURE study tests the feasibility of starting patients on a novel incremental HD regime. This regime is relatively short and has fixed increments in treatment times. It aims to make patient transition smoother in to dialysis dependency. Early data point towards an encouraging levels of patient interest in the study. The outcome of this trial will be used to design a future RCT of incremental HD vs. conventional treatment.