FAQs
General
Our team will randomize (un-blinded) patients to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L.
The Dial-Bicarb trial aims 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 in hemodialysis (HD) centers across Ontario.
Care Providers and Healthcare Personnel
Dialysis units are compensated for time spent implementing the intervention, handing out patient flyers, collecting monthly adherence data as outlined in the clinical trials agreement.
To ensure patients, especially new incoming patients, are correctly assigned their dialysate bicarbonate concentration it may be helpful to set or pre-program a unit-wide medical directive for the dialysate bicarbonate concentration i.e “per unit protocol.” It may also be helpful to re-visit training materials, keep a copy of the randomization scheme handy, and promptly provide monthly adherence reports to the units. We will work with sites to implement and maintain a high adherence to the assigned bicarbonate concentration.
- Ensure patients are assigned to their designated dialysate bicarbonate concentration based on the last single digit of their OHIP number.
- The team will provide a table identifying which OHIP number should receive which dialysate bicarbonate concentration.
- Do not change the assigned dialysate bicarbonate concentration from 32 or 38mmol/L without a strong clinical indication.
- Ensure patients are assigned to their designated dialysate bicarbonate concentration based on the last single digit of their OHIP number.
- The team will provide a table identifying which OHIP number should receive which dialysate bicarbonate concentration.
- Alert nephrologist if patient deviates from their assigned dialysate bicarbonate concentration of either 32 or 38 mmol/L.
Our team will randomize patients with an expired OHIP number based on the last single digit of their expired number, but will be unable to randomize patients without an OHIP number.
Unless the nephrologist determines a clinical reason to do otherwise, the patient should continue on the assigned dialysate bicarbonate concentration while hospitalized.
Unless the nephrologist determines a clinical reason to do otherwise, the patient should continue on the assigned dialysate bicarbonate concentration.
Our patient partners have told us opting out will be unlikely because both dialysate bicarbonate concentrations are part of routine care. If a patient, or the patient’s Nephrologist, opts out of the assigned dialysate bicarbonate, please provide routine care as determined by your dialysis unit. Patients are unable to opt out of data collection, as all patient data is being collected via routinely collected administrative healthcare databases.
Patients
Patients are unable to opt out of data collection, as all patient data is being collected via routinely collected administrative healthcare databases. Patients are able to decline receiving the assigned dialysate bicarbonate.
Yes! Our research team has several patient partners with lived experience. As active members of the research team, patient partners help design and implement the trial.
Nothing. Patients will receive the trial intervention during their routine dialysis visits.
Patients can speak to their Nephrologist or dialysis unit nursing staff if they have questions about their care. They can also reach out to the research team at DialBicarbCanada@lhsc.on.ca.
Kidney disease places a heavy burden on patients, their families and caregivers, and the health care system. For persons whose kidneys have failed, dialysis represents a treatment that can prolong life. However, those on dialysis can face a poor quality of life, high morbidity and mortality, and high health care costs. Understanding optimal treatment conditions, including components of the fluid used in dialysis, could ease these burdens.
No. Patients will not be compensated to participate in the trial, as it will occur during their routine dialysis visits.