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

Renal Failure Clinical Trial

Official title:

Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate for People Receiving Maintenance Hemodialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06270134
• Other study ID #: 14410
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: January 2029

Study information

• Verified date: February 2024
• Source: McMaster University
• Contact: Amber Molnar, MD
• Phone: (905) 522-1155
• Email: amolnar[@]stjosham.on.ca
• Is FDA regulated: No
• Study type: Interventional

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

Description:

Background: 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.

Objective: In outpatients 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 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. 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 trial participation. 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 3.7A62.

Data Collection: This trial will obtain information on patient characteristics and outcomes from provincial healthcare administrative databases, information that is already collected as part of routine healthcare.

Planned Analysis: The primary outcome is a recurrent event of non-elective all-cause hospitalizations or all-cause mortality. The treatment effect will be reported as a rate ratio 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 units globally at no added cost. This change in practice could help reduce hospitalizations and premature deaths among the more than 2 million people on hemodialysis worldwide.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients at participating dialysis units who have received hemodialysis for at least 90 days

Exclusion Criteria:

• Patients on in-centre nocturnal hemodialysis or in-centre frequent (greater than four times weekly) hemodialysis

Related Conditions & MeSH terms

• Hemolysis
• Renal Failure
• Renal Insufficiency

Intervention

Other:
• Bicarbonate
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-elective hospitalizations or mortality	All-cause non-elective hospitalizations or all-cause mortality.	Duration of the study, 4 years.
Secondary	Hospitalizations and fractures	Cardiovascular-related hospitalizations, infection-related hospitalizations, and fractures.	Duration of the study, 4 years.