A Pragmatic Randomized Clinical Trial: Twice-weekly vs Thrice-weekly Incident hemoDialysis in Elderly Patients

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Soonchunhyang University Hospital Bucheon
RECRUITING
Bucheon-si
Hallym University Medical Center- Chuncheon
COMPLETED
Chuncheon
Kangbuk Samsung Medical Center
COMPLETED
Seoul
Koera University Guro Hospital
COMPLETED
Seoul
Soonchunhyang University Seoul Hospital
ACTIVE_NOT_RECRUITING
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
COMPLETED
Seoul
Yonsei University, Wonju Severance Christian Hospital
COMPLETED
Wŏnju
Contact Information
Primary
Soon Hyo Kwon, MD
ksoonhyo@schmc.ac.kr
+8227099177
Backup
Sook Kim
himoomin@naver.com
+8227099177
Time Frame
Start Date: 2021-11-23
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 428
Treatments
Active_comparator: Twice-weekly hemodialysis with incremental approach
No_intervention: Thrice-weekly hemodialysis
Sponsors
Collaborators: Ministry of Health & Welfare, Korea
Leads: Soonchunhyang University Hospital

This content was sourced from clinicaltrials.gov