Health TrialsbyHealthPanel

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

ConditionsRenal FailureHemodialysis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bicarbonate

    Other intervention

    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.

Treatment groups

14,000 Participants
are divided into 2 treatment groups
Group A: Lower dialysate bicarbonate concentration (32 versus mmol/L)Active comparator 1 intervention
Group B: Higher dialysate bicarbonate concentration (38 mmol/L)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Non-elective hospitalizations

All-cause recurrent non-elective hospitalizations

Time frame
Duration of the study, 4 years.
2

Mortality

All-cause mortality

Time frame
Duration of the study, 4 years.

Secondary outcomes

1

Hospitalizations and fractures

Cardiovascular-related hospitalizations, infection-related hospitalizations, and fractures.

Time frame
Duration of the study, 4 years.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

ACT

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: