Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorSoonchunhyang University Hospital

About this trial

As Korea is becoming a super-aged society, the number of elderly patients with end-stage kidney disease (ESKD) is expected to increase rapidly. Therefore, the burden on Korean society will also increase.

Thrice-weekly hemodialysis is standard for renal replacement therapy. However, this regimen has not been validated for elderly ESKD patients with residual renal function. Elderly patients can have multiple comorbidities such as hypertension, diabetes, cardiovascular disease, and impaired physical activity. Frequent hemodialysis could provoke falls, hypotension, and cognitive impairment. Previous reports have suggested the potential benefit of twice-weekly hemodialysis with incremental increases in frequency when residual renal function decreases. In addition, twice-weekly hemodialysis decreases hospitalization rates in frail patients.

Therefore, the investigators hypothesized initiating renal replacement therapy with twice-weekly hemodialysis decreases the hopsitalizatoin rates compared with conventional thrice-weekly hemodialysis in elderly ESRD patients with residual renal function. This study is a pragmatic randomized clinical trial, multicenter study. Study subjects are incident ESRD patients (\>= 60 years old, n=428) with residual urine volume ( \> 500 mL/day) and follow up up to 2 years. Twice-weekly hemodialysis could be incremented according to clinical situations such as volume overload, hyperkalemia and uremic symptom. Primary outcome of this study is hospitalization rate during follow-up. Secondary outcomes include dialysis related hospitalization rate, the length of hospital stay, complication of dialysis,mortality rate and assessments of quality of life, frailty, and cost-utility.

Eligibility criteria

Qualifiers

Age ≥60 years

Clinical diagnosis of end stage kidney disease

Starting maintenance hemodialysis within one month

24-hour urine output ≥ 500 ml at randomization

Disqualifiers

Left ventricular ejection fraction < 40%)

Liver cirrhosis

Current treatment for an active malignancy or active infection

Onability or refusal to provide written informed consent

Trial design

Treatments tested in this trial

  • Hemodialysis

Treatment groups

428 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Soonchunhyang University Hospital

Lead sponsor

Ministry of Health & Welfare, Korea

Collaborator