Actively Recruiting
Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients
Led by Soonchunhyang University Hospital · Updated on 2026-05-11
428
Participants Needed
7
Research Sites
235 weeks
Total Duration
On this page
Sponsors
S
Soonchunhyang University Hospital
Lead Sponsor
M
Ministry of Health & Welfare, Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Clinical diagnosis of end stage kidney disease
- Starting maintenance hemodialysis within one month
- 24-hour urine output at least 500 milliliters at randomization
- Sufficient understanding of the study procedures and requirements
You will not qualify if you...
- Left ventricular ejection fraction less than 40%
- Liver cirrhosis
- Current treatment for an active malignancy or active infection
- Inability or refusal to provide written informed consent
- Enrollment in another clinical trial
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Soonchunhyang University Hospital Bucheon
Bucheon-si, South Korea
Actively Recruiting
2
Hallym University Medical Center- Chuncheon
Chuncheon, South Korea
Completed
3
Soonchunhyang University Seoul Hospital
Seoul, South Korea, 04401
Active, Not Recruiting
4
Kangbuk Samsung Medical Center
Seoul, South Korea
Completed
5
Koera University Guro Hospital
Seoul, South Korea
Completed
6
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Completed
7
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, South Korea
Completed
Research Team
S
Soon Hyo Kwon, MD
CONTACT
S
Sook Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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