Adult patients with end stage kidney disease requiring hemodialysis Digestive System Chronic kidney disease, stage 5
Conditions
Interventions
Experimental Arm
Incremental HD: Participants will initiate HD at a frequency of 2x/week and continue until an indication for an increase to 3x/week (trigger point) is reached. Trigger points include
Sponsors
Canadian Institutes of Health Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (=18 years old) starting HD as their initial dialysis therapy 2. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Urine output <0.5 l/day 2. Unlikely to be on dialysis for =1 year Since RKF and QOL at 18 months are secondary outcomes, adequate urine output at HD start and likelihood of needing chronic maintenance HD long-term are required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life (QOL) assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF 1.3) at 6 months after HD start | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Residual kidney function (RKF) (difference in mean of 24-hour urinary urea and creatinine clearances between groups) at baseline, months 3, 6, 12 and 18 2. Anuria: the proportion of patients with anuria (<200 ml urine output/24 h) and time to anuria at baseline, months 3, 6, 12 and 18 3. Safety (time to all-cause mortality; time to first major cardiovascular event [MACE]; number of non-elective hospital admissions and total hospital days; time to death and hospital admissions, episodes of hyperkalemia [=6.5 mmol/L]; extra HD sessions for fluid overload; vascular access procedures [SONG-HD core outcome]) assessed at monthly visits for 18 months 4. Quality of life measured using monthly EQ-5D-5L and quarterly KDQOL-SF 1.3 (all components) at baseline and monthly for 18 months 5. Symptom scores assessed by KDQOL-SF 1.3 (physical component and mental component summaries) at baseline, months 3, 6, 9, 12, 15, 18 6. Fatigue assessed by SONG-HD core outcome measure at baseline, months 3, 6, 9, 12, 15 and 18 7. Nutritional status assessed by Subjective Global Assessment (SGA) at baseline, months 3, 6, 12 and 18 8. Cost analysis recorded by participants in the Health Care Diary collected at baseline and monthly for 18 months | — |
Countries
Australia, Canada, New Zealand
Outcome results
None listed