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Search / Trial NCT06270134

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

Launched by MCMASTER UNIVERSITY · Feb 13, 2024

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Bicarbonate Renal Failure Kidney Pragmatic Trial Maintenance Hemodialysis

ClinConnect Summary

The Dial-Bicarb Trial is a study designed to find out if using a lower or higher concentration of bicarbonate in dialysis fluid can improve health outcomes for patients with kidney failure receiving hemodialysis. In this trial, patients will be randomly assigned to one of two groups: one group will receive a bicarbonate concentration of 32 mmol/L, while the other group will receive 38 mmol/L. This study will take place in various dialysis units across Ontario and aims to provide insights that could benefit patient care.

To be eligible for this trial, participants must be adults aged 18 or older who have been receiving hemodialysis for at least three months. It's important that their dialysis center and doctors agree to their participation in the study. However, patients who receive nocturnal hemodialysis or more frequent treatments (more than four times a week) will not be included in the trial. For those who participate, the trial will be integrated into their regular dialysis routine, and they will be monitored as part of their ongoing care. This trial is still in the planning stages and is not yet recruiting participants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • - 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).

About Mcmaster University

McMaster University, a leading research institution located in Hamilton, Ontario, Canada, is renowned for its innovative approach to education and its commitment to advancing healthcare through rigorous clinical research. The university's diverse research programs are supported by a multidisciplinary team of experts dedicated to improving patient outcomes and public health. With a strong emphasis on evidence-based medicine, McMaster University actively engages in clinical trials that explore new therapies, interventions, and health technologies, fostering collaboration among researchers, healthcare professionals, and industry partners to translate findings into real-world applications.

Locations

Patients applied

0 patients applied

Trial Officials

Amit Garg, MD

Principal Investigator

LHSC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported