About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged 70 or above
have developed end stage kidney disease and require hemodialysis treatment
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Twice weekly hemodialysis
Other interventionTwice weekly hemodialysis
Thrice weekly hemodialysis treatment
Other interventionThis arm will receive three hemodialysis treatments per week
Treatment groups
Trial outcomes
Primary outcomes
Days Alive and Out of Hospital
Days Alive and Out of Hospital is an important patient-centered goal and outcome that approximates time spent at home.
Secondary outcomes
Days Alive and Out of Hospital
Days Alive and Out of Hospital is an important patient-centered goal and outcome that approximates time spent at home
Quality-adjusted life years
Impact of treatment frequency on Quality-adjusted life years
Change in Edmonton Symptom Assessment Scale-revised Renal score from baseline to average of all follow-up assessments
Impact of treatment frequency on Quality of Life measures as assessed by the Edmonton Symptom Assessment Scale-revised Renal instrument (range 0-120 with higher scores mean a worse quality of life)
Change in Kidney Dialysis and Quality of Life-36 scores from baseline to average of all follow-up assessments
Impact of treatment frequency on quality of life as assessed by the Kidney Dialysis and Quality of Life-36 instrument (Each subscale score ranges from 0-100 where higher scores mean a better quality of life)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: