Active, Not Recruiting

This study is ongoing but no longer accepting new participants.

Outcomes of a Higher vs. Lower Hemodialysate Magnesium Concentration (Dial-Mag Canada)

NCT04079582Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sAmit GargAmit Garg

About This Study

This pragmatic, cluster-randomized trial evaluates the clinical impact of dialysate magnesium concentrations in outpatients receiving maintenance hemodialysis. Participating centers are randomized to a higher dialysate magnesium concentration of 1.5 mEq/L (0.75 mmol/L) or a lower concentration of ≤1.0 mEq/L (≤0.5 mmol/L). The study aims to determine if increasing dialysate magnesium reduces the risk of all-cause mortality and cardiovascular-related hospitalizations. Secondary outcomes include the frequency of intradialytic muscle cramps and other patient-reported measures. The trial utilizes routinely collected healthcare data to assess outcomes across a broad, representative population of patients with end-stage kidney disease.

Who Can Participate?

Inclusion Criteria

  • Inclusion Criteria: This pragmatic cluster randomized controlled trial has only two
  • The hemodialysis centre, or a group of hemodialysis centers combined into one cluster, must care for at least 15 outpatients being treated with in-centre maintenance hemodialysis.
  • The medical director of the hemodialysis centre must be willing for their centre to be randomized and to adopt the allocated dialysate Mg protocol as their standard solution for the duration of the trial.

Exclusion Criteria

  • The centre, or group of hemodialysis centres cares for less than 15 patients being treated with conventional in-centre hemodialysis.