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Clinical Trials in South Korea / NCT06141798
Recruiting Not applicable

Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients

NCT06141798 · tracked via the Priya Life Science South Korea tracker
Sponsor
Soonchunhyang University Hospital
Phase
Not applicable
Started
2021-11-23
Last updated
2026-05-11

Condition(s) studied

Age ProblemDialysis; ComplicationsFrailtyQuality of Life

Investigational drug(s) / intervention(s)

Hemodialysis

Hemodialysis: Number of weekly hemodialysis treatment

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Hospitalization rate — Follow up: 2 years
    The total number of hospitalizations per 100 person-years

Trial sites (7)

FacilityCityRegionStatus
Soonchunhyang University Hospital Bucheon Bucheon-si South Korea Recruiting
Hallym University Medical Center- Chuncheon Chuncheon South Korea Completed
Soonchunhyang University Seoul Hospital Seoul South Korea Active Not Recruiting
Kangbuk Samsung Medical Center Seoul South Korea Completed
Koera University Guro Hospital Seoul South Korea Completed
The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul South Korea Completed
Yonsei University, Wonju Severance Christian Hospital Wŏnju South Korea Completed

More Soonchunhyang University Hospital trials in South Korea

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Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy Recruiting
PROGAIN Trial in Gastric Cancer Surgery Recruiting

Other trials for the same condition

South Korean Study to Prevent Frailty and Aging-related Diseases Through Lifestyle Intervention Recruiting
Personalized Health Coaching for Patients With HF Recruiting
Patient-centered REhabilitation Program to Advance REcovery Starting soon
SupporTive Care At Home Research for Patients With Advanced Cancer (STAHR-cancer) Recruiting
The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Undergoing Hemodialysis: A Pilot Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06141798 on ClinicalTrials.gov ↗ ← All trials in South Korea