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Previous Trials

In most hospitals and dialysis centres, the temperature of dialysis fluid, or dialysate, is set at 36.5 °C to match body temperature. The Major Outcomes with Personalized Dialysate TEMPerature (MyTEMP) Trial was a pragmatic, registry-based cluster-randomized trial focused on determining whether reducing the dialysate temperature by 0.5 °C below body temperature could improve cardiovascular outcomes. [READ MORE]

MyTEMP logo
Dial-Mag Logo

Dialysate, the fluid used in dialysis, is a critical component of the treatment, yet little evidence is available to guide its optimal formulation.

In particular, the concentration of magnesium in dialysis has received little scientific attention until recently, with new research suggesting that a higher dialysate magnesium concentration may benefit patients. The Dialysate Magnesium (Dial-Mag) Trial is a large-scale randomized pragmatic clinical trial focused on determining whether different concentrations of magnesium in dialysate is associated with improved outcomes for dialysis patients. It is currently running in four provinces in over 140 hemodialysis centres. Through this trial, we hope to determine the optimal concentration of dialysate magnesium for patient health. [READ MORE]

The Randomized Evaluation of SOdium dialysate Levels on Vascular Events (RESOLVE) trial is an ongoing collaboration with The George Institute for Global Health in Australia, involving more than 300 hemodialysis centres worldwide. This multi-national initiative trial aims to establish whether treatment with a dialysate sodium concentration of 137 mmol/L, rather than 140 mmol/L, reduces cardiovascular events and death in hemodialysis patients. To date, 12 participating Ontario hemodialysis centres have been randomly allocated to a dialysate sodium concentration of 137 mmol/L or 140 mmol/L. We are continuing further recruitment at other sites and are finalizing the analytic plan to aggregate data from Canada with global data. The trial started in 2017 with follow-up expected to end within four to six years.

Our team focuses on cultivating the next generation of researchers and enriching the talents of investigators by running a unique training program that gives investigators, patients, clinicians, and health care administrators the knowledge, skill, and support to prepare promising interventions for large-scale RCTs in hemodialysis. The following trials are currently being developed.

PI: Dr. Kristin Clemens

Patients on hemodialysis live with a fragility fracture risk that is more than 10-fold higher than the general population, but there remains a surprising lack of research into how to prevent such fractures in this population. The PRevEnting FractuRes in REnal Disease 1 (PREFERRED-1) pilot trial is meant to address this knowledge gap. The team advancing this trial, comprised of endocrinologists, nephrologists, geriatricians, researchers, and patients, is testing the intervention in a randomized, controlled pilot trial is Denosumab a monoclonal antibody commonly used in the treatment of osteoporosis (alongside supplemental calcium, vitamin D, and close bloodwork monitoring).

In the PREFERRED-1 pilot trial, the intervention will be embedded in routine care delivered by the participants’ existing kidney care staff. Participants will be followed in their dialysis units, and the outcomes will be captured using ICES databases including the CIHI-DAD (hospital encounters), NACRS (emergency department encounters), OLIS Database (lab data), and the Ontario Drug Benefits Database (medication data). The PREFERRED-1 pilot study, will help investigators determine if a larger fracture-outcomes trial of denosumab is feasible in routine care.

The pilot trial is set to begin in 2022 and wishes to establish the trial is highly feasible in at least six hemodialysis centres.

PI: Melissa Schorr

Patients living with chronic kidney disease often struggle with fluid retention, which can cause hypertension and undue cardiovascular stress. If the patient is receiving dialysis, a portion of this fluid retention can be managed by taking extra fluid off during dialysis, but patients often find it harder to tolerate dialysis if the removal of fluid during the procedure is more aggressive, which can cause significant drops in blood pressure or muscle cramps. Furthermore, changes in hemodynamics can have a significant negative impact on cardiovascular and neurological outcomes.

These patients are often prescribed diuretics to manage this fluid retention. Our team wanted to determine the effectiveness of diuretics for patients on hemodialysis. Focusing on patients who still make some urine or have some residual renal function, they asked whether diuretics can help preserve urine output and residual renal function and does this treatment lead to lower interdialytic weight gain. Furthermore, they wanted to know, if the diuretics lower the risk of major adverse cardiac events or death.

To address this, the diuretic use in patients with residual renal function on hemodialysis (DIURESED) trial is being designed as a five-part study that will include a narrative review, observational study, medication dosage study, feasibility, and large-scale trial to investigate the use of diuretic medications in patients on hemodialysis who still have some residual renal function. We are completing a narrative literature review of diuretic use in hemodialysis patients and an ICES dataset-creation plan to analyze historic administrative health data to inform the development of the trial. We have also developed a single centre dose-finding study protocol which is being submitted for ethics approval.

Currently, the team is focused on the patterns of diuretics use and urine output patterns in hemodialysis patients using historical data housed at ICES. The goal is for the dose-finding trial to begin in fall 2022.

PIs: Amber Molnar & Sam Silver

Hemodialysis is used to treat metabolic acidosis often caused by kidney failure. To do this, bicarbonate is added to the dialysate. However, the optimal dialysate bicarbonate concentration is not known and there is no current standard for concentration use. Some dialysis units deliver a single bicarbonate concentration to all patients while others adjust the bicarbonate concentration depending on a patient’s pre-dialysis serum bicarbonate concentration.

Guidelines suggest that providers should use a pre-dialysis serum bicarbonate target >=22 mmol/L, but this is based on weak evidence. Research conducted in small trials suggests correcting metabolic acidosis has positive effects on nutrition, muscle mass, insulin sensitivity and bone metabolism. However, large observational studies show that a higher dialysate bicarbonate concentration is associated with increased mortality.

The Dial-Bicarb Trial, a large-scale pragmatic RCT, is currently being designed to address this knowledge gap, intending to ultimately determine which dialysate concentration of bicarbonate is best for patient health. To inform the trial design, a retrospective cohort study is being completed, using ICES databases including the Canadian Organ Replacement Registry (CORR – vital organ transplantation and renal dialysis activity), Discharge Abstract Database (DAD – hospital encounters), Ontario Health Insurance Plan Claims (OHIP – paid claims), Ontario Laboratories Information System (OLIS – lab data), the Registered Persons Database (RPDB – demographics), NephroCare® (dialysate session data), and the Ontario Drug Benefits Claims (ODB – medication data).

With the help of our patient partners and the support of ethicists, this trial is designed to improve the quality of life for patients on dialysis. An application to fund the larger trial is under peer review.