Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University
About this trial
This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel.
Eligibility criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Bicarbonate
Treatment groups
14,000 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
McMaster University
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
ACT
Collaborator
Source ClinicalTrials.gov