Dialysis Less Frequently in the Elderly

Official title

A Randomized Controlled Study of Dialysis Less Frequently in the Elderly

Overview

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.

Interventions

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

Primary outcome measures

• Days Alive and Out of Hospital [Time frame: 365 days]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 11 centers

• 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
• … and 3 more centers

Publications

• 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

Identifiers

NCT: NCT07738731 · 6046152

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗