Quality of Life Clinical Trial
Official title:
A Pragmatic Randomized Clinical Trial: Twice-weekly vs Thrice-weekly Incident hemoDialysis in Elderly Patients
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.
Status | Recruiting |
Enrollment | 428 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Soonchunhyang University Hospital Bucheon | Bucheon | |
Korea, Republic of | Hallym University Medical Center- Chuncheon | Chuncheon | |
Korea, Republic of | Kangbuk Samsung Medical Center | Seoul | |
Korea, Republic of | Koera University Guro Hospital | Seoul | |
Korea, Republic of | Soonchunhyang University Seoul Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | |
Korea, Republic of | Yonsei University, Wonju Severance Christian Hospital | Wonju |
Lead Sponsor | Collaborator |
---|---|
Soonchunhyang University Hospital | Ministry of Health & Welfare, Korea |
Korea, Republic of,
Han M, Jeon H, Yu BC, Song SH, Chung S, Lim C, Sohn H, Noh JW, Kwon SH; PRIDE Research Group. A Pragmatic Randomized clinical trial: twice-weekly vs. thrice-weekly Incident hemoDialysis in Elderly patients (PRIDE): study protocol. Kidney Res Clin Pract. 2023 Dec 18. doi: 10.23876/j.krcp.23.177. Online ahead of print. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospitalization rate | The total number of hospitalizations per 100 person-years | Follow up: 2 years | |
Secondary | Dialysis related hospitalization rate | The total number of dialysis hospitalizations per 100 person-years | Follow up: 2 years | |
Secondary | Length of Hospital Stay | per 1000 person-days | Follow up: 2 years | |
Secondary | Complication of dialysis | Any complication of dialysis associated | Follow up: 2 years | |
Secondary | Mortality rate | Any cause of death | Follow up: 2 years | |
Secondary | The Clinical Frailty Scale | One item, minimum point: 1, maximum point: 9, High scores means worse outcome | Follow up: 2 years | |
Secondary | Cost effective | Incremental Cost-Effectiveness Ratio, Higher scores means better | Follow up: 2 years | |
Secondary | Kidney Disease Quality of Life Instrument (KDQOL) | 24 items, minimum point 1, maximum point 5, high score means worse outcomes | Follow up: 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |