Dialysis Less Frequently in the Elderly

Официальное название

A Randomized Controlled Study of Dialysis Less Frequently in the Elderly

Обзор

Many people who have kidney failure require hemodialysis treatments to stay alive. Hemodialysis is a procedure that cleans the blood of the toxins and fluids that build up when kidneys don't work. Most patients receive hemodialysis treatment three times every week and each treatment lasts 4 hours. These patients spend 156 days per year receiving hemodialysis treatments. This is a very large time burden which has a tremendous impact on well-being and life satisfaction. Current usual approach of prescribing three hemodialysis treatments per week is not based on good studies and assumes that all people need the same number of hemodialysis treatments per week regardless of their age, values, life expectancy or other health conditions. Over time, increasingly more elderly people are needing to start hemodialysis treatments. The investigators have conducted a preliminary study that shows that patients who are 70 years of age or older can do well when only receiving only two hemodialysis treatments per week. In this preliminary study, receiving two hemodialysis treatments per week was no different than three hemodialysis treatments per week with regards to important safety measures including blood values and management of body fluid levels. The investigators now propose to carry out a much larger study in many centers across Canada that will compare two times per week hemodialysis treatments to three times per week hemodialysis treatments in elderly patients who have reached kidney failure and are beginning their hemodialysis journey. The investigators want to know if receiving hemodialysis treatments twice per week increases the number of days that a patient is able to spend at home without increasing rates of hospitalization or death compared to receiving hemodialysis treatments three times per week. The investigators also want to know if this is better for people's quality of life, safe, less expensive for the health care system and friendlier to the environment. The results of this study will help elderly patients needing to start hemodialysis treatments, medical care teams who help make decisions about how many hemodialysis treatments per week are necessary as well as kidney organizations that oversee kidney care for patients in Canada and around the world.

Вмешательства

• Другое Twice weekly hemodialysis
  Twice weekly hemodialysis
• Другое Thrice weekly hemodialysis treatment
  This arm will receive three hemodialysis treatments per week

Первичные конечные точки

• Days Alive and Out of Hospital [Срок оценки: 365 days]

Вторичные конечные точки (12)

• Days Alive and Out of Hospital [Срок оценки: 2 years]
• Quality-adjusted life years [Срок оценки: 2 years]
• Change in Edmonton Symptom Assessment Scale-revised Renal score from baseline to average of all follow-up assessments [Срок оценки: 2 years]
• Change in Kidney Dialysis and Quality of Life-36 scores from baseline to average of all follow-up assessments [Срок оценки: 2 years]
• Clinical Frailty Scale score [Срок оценки: 2 years]
• Number of urgent unscheduled hemodialysis treatment for hyperkalemia [Срок оценки: 2 years]
• Number of urgent unscheduled hemodialysis treatment for volume overload [Срок оценки: 2 years]
• Weekly pre-hemodialysis potassium levels > 5.9 mmol/L [Срок оценки: 2 years]
• Change in urine volume [Срок оценки: 2 years]
• Hospitalization [Срок оценки: 2 years]
• Kidney function recovery [Срок оценки: 2 years]
• Elective withdrawal from hemodialysis treatment [Срок оценки: 2 years]

Критерии участия

Критерии включения

• patients aged 70 or above
• have developed end stage kidney disease and require hemodialysis treatment

Критерии исключения

• Hospitalized patients without an alternate level of care designation
• Those with missed hemodialysis sessions due to non-adherence during the first 7 weeks of hemodialysis treatment
• Patients already prescribed twice weekly hemodialysis
• Patients who are medically unsuitable as per primary care team and site investigator
• anticipated significant barriers to ascertainment of patient-reported experience measures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 11 центров

• Multiple Sites — Vancouver
• Memorial University — St. John's
• Dalhousie University — Halifax
• Queen's University — Kingston
• CHUM — Montreal
• Hopital du Sacre-Coeur-de-Montreal — Montreal
• Hopital du Sacre-Coeur-de-Montreal — Montreal
• Hopital Maisoneuve-Rosemont — Montreal
• … и ещё 3 центра

Публикации

• Moorman D, Pilkey NG, Goss CJ, Holden RM, Welihinda H, Kennedy C, Halliday SM, White CA. Twice versus thrice weekly hemodialysis: A systematic review. Hemodial Int. 2022 Oct;26(4):461-479. doi: 10.1111/hdi.13045. Epub 2022 Sep 12. PMID 36097718
• White CA, Day AG, Holden RM. Response to the Letter to the Editor Entitled "Twice- Versus Thrice-Weekly Hemodialysis in the Elderly: Are we 'DLITE'd? Kidney Int Rep. 2026 Jan 19;11(4):103782. doi: 10.1016/j.ekir.2026.103782. eCollection 2026 Apr. No abstract available. PMID 41717127
• White CA, Welihinda H, Day AG, Heyland DK, Holden RM. Pilot Randomized Trial of Dialysis Less Frequently in the Elderly: The DLITE Study. Kidney Int Rep. 2025 Sep 3;10(11):3796-3809. doi: 10.1016/j.ekir.2025.08.043. eCollection 2025 Nov. PMID 41278339

Идентификаторы

NCT: NCT07738731 · 6046152

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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