A Randomized Controlled Study of Dialysis Less Frequently in the Elderly
| Registry | NCT07738731, acronym DLITE |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 210 (Estimated) |
| Sponsor | Queen's University (Other) |
| Conditions | Hemodialysis, End Stage Kidney Disease (ESKD) |
| Interventions | Twice weekly hemodialysis, Thrice weekly hemodialysis treatment (Other) |
| Dates | start 2026-10-01 (estimated), primary completion 2031-10-01 (estimated), completion 2031-10-01 (estimated), first posted 2026-07-31, last updated 2026-07-31 |
| Locations | 11 sites in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Hemodialysis All trials for End Stage Kidney Disease (ESKD) All trials of Twice weekly hemodialysis All trials of Thrice weekly hemodialysis treatment
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Twice weekly hemodialysis treatment | Experimental | Other: Twice weekly hemodialysis | This arm will receive two hemodialysis treatments per week |
| Thrice weekly hemodialysis treatment | Active comparator | Other: Thrice weekly hemodialysis treatment | This arm will receive three dialysis treatments per week |
Sex: All, ages: 70 Years to any
Inclusion Criteria: 1. patients aged 70 or above 2. have developed end stage kidney disease and require hemodialysis treatment Exclusion Criteria: 1. Hospitalized patients without an alternate level of care designation 2. Those with missed hemodialysis sessions due to non-adherence during the first 7 weeks of hemodialysis treatment 3. Patients already prescribed twice weekly hemodialysis 4. Patients who are medically unsuitable as per primary care team and site investigator 5. anticipated significant barriers to ascertainment of patient-reported experience measures
| Facility | City | Country | Status |
|---|---|---|---|
| Multiple Sites | Vancouver, British Columbia | Canada | |
| Memorial University | St. John's, Newfoundland and Labrador | Canada | |
| Dalhousie University | Halifax, Nova Scotia | Canada | |
| Queen's University | Kingston, Ontario | Canada | |
| CHUM | Montreal, Quebec | Canada | |
| Hopital du Sacre-Coeur-de-Montreal | Montreal, Quebec | Canada | |
| Hopital du Sacre-Coeur-de-Montreal | Montreal, Quebec | Canada | |
| Hopital Maisoneuve-Rosemont | Montreal, Quebec | Canada | |
| Hôpital du Haut-Richelieu | Montreal, Quebec | Canada | |
| McGill University | Montreal, Quebec | Canada | |
| Centre de Recherche du CHU de Quebec: Laval University | Québec, Quebec | Canada |