Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients
Trial Parameters
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Brief Summary
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
Inclusion Criteria: * Age ≥60 years * Clinical diagnosis of end stage kidney disease * Starting maintenance hemodialysis within one month * 24-hour urine output ≥ 500 ml at randomization * Sufficient understanding of the study procedures and requirements. Exclusion Criteria: * Left ventricular ejection fraction \< 40%) * Liver cirrhosis * Current treatment for an active malignancy or active infection * Onability or refusal to provide written informed consent * enrollment in another clinical trial.