Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate

NCT06270134 | Not Yet Recruiting DMC

• 1 other identifier: 14410
• Study Type: interventional
• Target: 14,000
• Locations: 0 countries
• Sites: N/A

Brief 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 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel.

Conditions

Renal Failure; Hemodialysis

Keywords

bicarbonate; renal failure; kidney; pragmatic trial; maintenance hemodialysis

Outcome Measures

Primary Outcomes (2)

• Non-elective hospitalizations

  All-cause recurrent non-elective hospitalizations

  Duration of the study, 4 years.

• Mortality

  All-cause mortality

  Duration of the study, 4 years.

Secondary Outcomes (1)

• Hospitalizations and fractures

  Duration of the study, 4 years.

Study Arms (2)

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.

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.

Other: Bicarbonate

Interventions

Bicarbonate OTHER

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.

Higher dialysate bicarbonate concentration (38 mmol/L); Lower dialysate bicarbonate concentration (32 versus mmol/L)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• ACT: collaborator

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Bicarbonates

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Anions; Ions; Electrolytes

Study Officials

• Amit Garg, MD

  LHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber Molnar, MD

CONTACT

(905) 522-1155; amolnar@stjosham.on.ca

Amit Garg, MD

CONTACT

519-685-8502; Amit.Garg@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share