Renal FailureNCT06270134
Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate
A study testing Bicarbonate in people with Renal Failure and Hemodialysis, run by McMaster University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Hemodialysis
- What is being tested?
- Bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate for People Receiving Maintenance Hemodialysis
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.
Read the detailed description
Background: Bicarbonate is added to hemodialysis fluids to correct the metabolic acidosis that arises from kidney failure. Some dialysis centres in Canada add bicarbonate to a level of 32 mmol/L, while other centres add bicarbonate to a level of 38 mmol/L. It is unknown whether one level is better for people's health.
Objective: In patients receiving maintenance hemodialysis, to determine if providing a lower versus higher concentration of dialysate bicarbonate (32 versus 38 mmol/L) alters the risk of outcomes important to patients and their care providers.
Design, Setting, and Participants: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis centres across Ontario. Patients at each dialysis centre 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 centre personnel. The concentration of dialysate bicarbonate is altered for a hemodialysis session through a simple setting on the machine.
Altered approach to patient consent: The study team, which includes patient partners, proposes an opt-out altered approach to patient consent to receive the trial-assigned concentration of dialysate bicarbonate. This is under a framework that Dial-Bicarb fits the required parameters to do so, as constructed in Canada's Tri-Council Policy Statement-2 (TCPS-2) Article 3.7A.
Primary Outcome: Two primary outcomes, all-cause mortality and recurrent all-cause non-elective hospitalizations.
Secondary Outcomes: Cardiovascular-related hospitalizations, infection-related hospitalizations, and fractures.
Data Collection: This trial will obtain information on patient characteristics and outcomes from provincial healthcare administrative databases, which are already collected as part of routine healthcare.
Planned Analysis: Treatment effects will be reported as hazard ratios accounting for the number of events and total follow-up time within arms.
Potential Impact: If a lower concentration of dialysate bicarbonate is shown to be superior, it could be easily adopted as the standard of care by hemodialysis centres globally at little added cost. This change in practice could help reduce premature deaths and hospitalizations among the more than 2 million people on hemodialysis worldwide.
- Conditions
- Renal Failure, Hemodialysis
- Being tested
- Bicarbonate
- Keywords
- bicarbonate, renal failure, kidney, pragmatic trial, maintenance hemodialysis
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicarbonateOther
Bicarbonate is added to hemodialysis fluids to correct the metabolic acidosis that arises from kidney failure. Some dialysis units in Canada add bicarbonate to a level of 32 mmol/L, while other units add bicarbonate to a level of 38 mmol/L. It is unknown whether one level is better for people's health.
| Study group | Role | What they receive |
|---|---|---|
| Lower dialysate bicarbonate concentration (32 versus mmol/L) | Active comparator | 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 32 mmol/L. Receives: Other: Bicarbonate |
| Higher dialysate bicarbonate concentration (38 mmol/L) | Active comparator | 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 38 mmol/L. Receives: Other: Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-elective hospitalizations
All-cause recurrent non-elective hospitalizations
Measured: Duration of the study, 4 years.
Mortality
All-cause mortality
Measured: Duration of the study, 4 years.
Secondary outcomes (1)
Hospitalizations and fractures
Cardiovascular-related hospitalizations, infection-related hospitalizations, and fractures.
Measured: Duration of the study, 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study startApr 2025 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), ACT
- Responsible party
- Sponsor
- Investigators
- Amit Garg, MD, Principal investigator, LHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270134
- Sponsor's protocol ID
- 14410
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate for People Receiving Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT06270134
- Acronym / sponsor ID
- 14410
- Conditions
- Renal Failure, Hemodialysis
- Keywords
- bicarbonate, renal failure, kidney, pragmatic trial, maintenance hemodialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), ACT
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Bicarbonate is added to hemodialysis fluids to correct the metabolic acidosis that arises from kidney failure. Some dialysis centres in Canada add bicarbonate to a level of 32 mmol/L, while other centres add bicarbonate to a level of 38 mmol/L. It is unknown whether one level is better for people's health.
Objective: In patients receiving maintenance hemodialysis, to determine if providing a lower versus higher concentration of dialysate bicarbonate (32 versus 38 mmol/L) alters the risk of outcomes important to patients and their care providers.
Design, Setting, and Participants: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis centres across Ontario. Patients at each dialysis centre 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 centre personnel. The concentration of dialysate bicarbonate is altered for a hemodialysis session through a simple setting on the machine.
Altered approach to patient consent: The study team, which includes patient partners, proposes an opt-out altered approach to patient consent to receive the trial-assigned concentration of dialysate bicarbonate. This is under a framework that Dial-Bicarb fits the required parameters to do so, as constructed in Canada's Tri-Council Policy Statement-2 (TCPS-2) Article 3.7A.
Primary Outcome: Two primary outcomes, all-cause mortality and recurrent all-cause non-elective hospitalizations.
Secondary Outcomes: Cardiovascular-related hospitalizations, infection-related hospitalizations, and fractures.
Data Collection: This trial will obtain information on patient characteristics and outcomes from provincial healthcare administrative databases, which are already collected as part of routine healthcare.
Planned Analysis: Treatment effects will be reported as hazard ratios accounting for the number of events and total follow-up time within arms.
Potential Impact: If a lower concentration of dialysate bicarbonate is shown to be superior, it could be easily adopted as the standard of care by hemodialysis centres globally at little added cost. This change in practice could help reduce premature deaths and hospitalizations among the more than 2 million people on hemodialysis worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lower dialysate bicarbonate concentration (32 versus mmol/L) | Active comparator | Other: BicarbonatePatients 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 32 mmol/L. |
| Higher dialysate bicarbonate concentration (38 mmol/L) | Active comparator | Other: BicarbonatePatients 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 38 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BicarbonateBicarbonate is added to hemodialysis fluids to correct the metabolic acidosis that arises from kidney failure. Some dialysis units in Canada add bicarbonate to a level of 32 mmol/L, while other units add bicarbonate to a level of 38 mmol/L. It is unknown whether one level is better for people's health. | Other | Higher dialysate bicarbonate concentration (38 mmol/L), Lower dialysate bicarbonate concentration (32 versus mmol/L) |
Primary outcome
Non-elective hospitalizations
Time frame: Duration of the study, 4 years.
All-cause recurrent non-elective hospitalizations
Mortality
Time frame: Duration of the study, 4 years.
All-cause mortality
1 secondary outcome
Hospitalizations and fractures
Time frame: Duration of the study, 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Garg, MD principal investigator
LHSC
Questions about this trial
What is this clinical trial studying?
A study testing Bicarbonate in people with Renal Failure and Hemodialysis, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber Molnar, MD ((905) 522-1155 ext. 33787, amolnar@stjosham.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-elective hospitalizations (time frame: Duration of the study, 4 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.