Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients

Recruiting now · Not applicable

Conditions studied: Age Problem, Dialysis; Complications, Frailty, Quality of Life

In brief

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.

Key facts

Study ID

NCT06141798

Run by

Soonchunhyang University Hospital

People needed

428

Starts

2021-11-23

Expected to finish

2026-05-31

Last updated by the study team

2026-05-11

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Soonchunhyang University Hospital Bucheon — Bucheon-si, South Korea (enrolling)
• Hallym University Medical Center- Chuncheon — Chuncheon, South Korea
• Soonchunhyang University Seoul Hospital — Seoul, South Korea
• Kangbuk Samsung Medical Center — Seoul, South Korea
• Koera University Guro Hospital — Seoul, South Korea
• The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul, South Korea
• Yonsei University, Wonju Severance Christian Hospital — Wŏnju, South Korea

Full record on ClinicalTrials.gov

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