Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate
Actively Recruiting
About This Study
This pragmatic, open-label, randomized superiority trial compares the clinical outcomes of two standard dialysate bicarbonate concentrations in patients receiving maintenance hemodialysis. Participants are randomized 1:1 to receive a dialysate bicarbonate concentration of either 32 mmol/L or 38 mmol/L, with the intervention embedded into routine care. The study evaluates whether a lower versus higher concentration reduces the risk of the primary outcomes: all-cause mortality and recurrent non-elective hospitalizations. Secondary endpoints include cardiovascular-related hospitalizations, infection-related hospitalizations, and fractures. Data collection utilizes provincial administrative databases to track long-term outcomes within this Ontario-based population.
Who Can Participate?
✓ Inclusion Criteria
- •The dialysis centre director and all nephrologists who provide care in the centre agree to trial participation.
- •Adult patients 18 years of age and older, with a health card number, enter the trial after they receive hemodialysis for at least 90 days (about 3 months) so that patients with acute kidney injury who recover kidney function are excluded.
✗ Exclusion Criteria
- •Participating centres are instructed that patients on in-centre nocturnal hemodialysis or in-centre frequent (greater than four times weekly) hemodialysis are not in the trial (and do not receive the allocated intervention), since these patients usually receive dialysate bicarbonate concentrations ≤32mmol/L as standard care (based on Ontario registry data, these modalities represent <5% of the hemodialysis patient population).