End Stage Kidney Disease (ESKD), Hemodialysis
Conditions
Keywords
Hemodialysis treatment frequency, Elderly, Quality of Life, mortality
Brief summary
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
OTHERTwice weekly hemodialysis
Twice weekly hemodialysis
OTHERThrice weekly hemodialysis treatment
This arm will receive three hemodialysis treatments per week
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days Alive and Out of Hospital | 365 days | Days Alive and Out of Hospital is an important patient-centered goal and outcome that approximates time spent at home. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days Alive and Out of Hospital | 2 years | Days Alive and Out of Hospital is an important patient-centered goal and outcome that approximates time spent at home |
| Quality-adjusted life years | 2 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 | 2 years | 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 | 2 years | 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) |
| Clinical Frailty Scale score | 2 years | Average of all follow-up Clinical Frailty Scale score assessments controlling for baseline (range 1-9 with higher scores meaning higher frailty) |
| Number of urgent unscheduled hemodialysis treatment for hyperkalemia | 2 years | Impact of intervention on potassium control |
| Number of urgent unscheduled hemodialysis treatment for volume overload | 2 years | Impact of treatment frequency on volume overload |
| Weekly pre-hemodialysis potassium levels > 5.9 mmol/L | 2 years | Impact of treatment frequency on potassium control |
| Change in urine volume | 2 years | Impact of treatment frequency on volume of urine output |
| Hospitalization | 2 years | Impact of treatment frequency on the number and days of hospitalization |
| Kidney function recovery | 2 years | Impact of treatment frequency on the number of participants recovering kidney function |
| Elective withdrawal from hemodialysis treatment | 2 years | Impact of treatment frequency on the number of participants who choose to withdraw electively from hemodialysis treatment |
| Cost | 2 years | Impact of treatment frequency on health care cost attributed to hemodialysis treatment |
| Environmental costs attributed to hemodialysis treatment | 2 years | Impact of treatment frequency on the environmental cost attributed to hemodialysis treatment |
| mortality | 2 years | impact of treatment frequency on mortality |
Countries
Canada
Contacts
CONTACTChristine A White, MD
Outcome results
None listed