Pilot Randomized Trial of Dialysis Less Frequently in the Elderly: The DLITE Study

The elderly represent the most rapidly growing age group with end-stage kidney disease (ESKD) world-wide. The hemodialysis (HD) prescription that provides the best outcomes for this distinct population with reduced life expectancy is unknown. The primary objective of the DLITE pilot trial was to determine the feasibility and safety of conducting a trial designed to determine whether twice versus thrice weekly HD improves quality of life (QOL) and important clinical outcomes in elderly patients with HD.

We conducted a pilot single-center open randomized controlled trial (RCT) of patients aged ≥ 70 years of age who are on incident HD. Subjects were randomized to twice (n = 20) versus thrice (n = 20) weekly HD and followed for 9 months. There was no residual kidney function (RKF) trigger for HD prescription escalation. The primary outcomes were those of feasibility and safety. Secondary outcomes included QOL, hyperkalemia, mortality, and need for emergency HD.

Recruitment rate was 1.1 patients/mo. The consent rate of eligible subjects was high (77%), adherence was ≥ 99%, 96% of QOL surveys were completed, and 78% of randomized subjects completed the study. Pre-HD normokalemia rates for twice versus thrice weekly were 89% and 90%, respectively. Urgent HD treatments for hypervolemia and hyperkalemia, hospitalizations, and death were infrequent in both arms.

The results of this pilot RCT of twice versus thrice weekly HD in elderly patients on incident HD reveal that the study intervention was feasible and safe. These results will inform the design of a multicenter RCT with QOL, economic, morbidity, and mortality end points.