End-stage kidney disease (ESKD) poses a substantial public health challenge, with the
number of patients requiring renal replacement therapy (RRT) globally reaching 2.61
million in 2010 and projected to rise to 5.43 million by 2030. In Korea, the incidence of
hemodialysis (HD) has also been gradually increasing. The increase in HD incidence in
South Korea is significantly linked to the aging population. Korea is one of the most
rapidly aging countries in the world and the age of dialysis patients is also increasing,
with more than half over the age of 60.
HD has potential advantages over conservative management or peritoneal dialysis in older
adults, however, guidelines for optimal HD for the elderly have not yet been established.
Typically, patients receive HD three times a week, with only a small proportion of
patients receiving less frequent dialysis. However, potential disadvantages such as
hemodynamic stress, vascular access problems, bleeding, falls and economic cost should be
considered in older adults with ESKD.
In elderly patients, it is often difficult to maintain a thrice-weekly HD schedule due to
the presence of other medical conditions and the challenges of frailty. Elderly patients
have shown poor outcome even after initiation of HD. A study by Santos et al.
demonstrated a more than twofold increased risk of mortality at 6 months in patients
older than 75 years compared to those younger than 75. Another study using Japanese
National Dialysis Registry data revealed a 30% mortality rate in those aged over 80 years
within 1 year after initiation of HD, with frailty being one of the most important
factors associated with early death after initiation of HD. Excessive HD in elderly
patients can lead to malnutrition, low blood pressure during dialysis, poor quality of
life, depression, and stress due to physical and temporal activity restriction. The
increased risk of falls in HD patients is also a serious problem.
Incremental initiation of HD involves starting HD at a lower intensity than the standard
4 hours thrice weekly and gradually increasing the frequency and duration of dialysis as
kidney function declines. The decision to initiate patients on incremental HD can be made
based on clinical parameters such as urine volume or residual kidney function,
socio-economic factors such as financial limitations or insurance coverage, or lack of
availability of dialysis services. Current guidelines recommend that twice weekly
dialysis be performed in patients with kidney urea clearance greater than 3ml/min/1.73m2
or a urine output over 0.5 liter per day.
A systemic review and meta-analysis showed no difference in mortality, hospitalization
rates, or quality of life between patients receiving incremental and conventional HD,
with improved preservation of residual renal function and a reduction in dialysis cost
with incremental HD. One randomized controlled trial (RCT) showed no difference in
episodes of fluid overload or hyperkalemia, but an increased risk of hyperkalemia with
incremental HD. Another study showed lower hospitalization rate in incremental HD
compared to conventional dialysis. These studies demonstrate the need for a large RCT
comparing incremental and conventional HD.
However, current studies do not provide conclusive evidence on the benefits and risks of
incremental HD in elderly patients. Therefore, the investigators are conducting a
pragmatic RCT to determine whether the initiation of renal replacement therapy with
twice-weekly HD reduces hospitalization rates compared to conventional thrice-weekly HD
in older adults with ESKD.
Trial design PRIDE trial is designed as a pragmatic RCT comparing the effect of
initiating twice-weekly hemodialysis with an incremental approach compared to
thrice-weekly HD on hospitalization rates in elderly ESKD patients with RKF. A total of
428 participants will be recruited from 18 academic dialysis centers in Korea.
Participants will have the flexibility to transfer to other dialysis centers as needed.
The decision to increase dialysis frequency will be made by the treating physicians.
Hypothesis Our main hypothesis is that twice-weekly HD, when prescribed to older adults
with RKF will reduce hospitalization rates compared with thrice-weekly HD.
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