BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients

Sponsor
Elisabethinen Hospital
Study ID
NCT07663279
Status
Not Yet Recruiting

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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • D-Standard — OTHER
    Center's standard dialysate containing 32 mmol/L bicarbonate and 0.5 mmol/L magnesium
  • D-Bic — OTHER
    Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium held at 0.5 mmol/L
  • D-Mag — OTHER
    Dialysate magnesium increased to 1.0 mmol/L; dialysate bicarbonate held at 32 mmol/L
  • D-BicMag — OTHER
    Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium increased to 1.0 mmol/L

Study Details

The BicMag study is a prospective, randomized, controlled cross-over study that aims to examine the potential additive effect of a dialysate enriched with both bicarbonate and magnesium on mineral buffering capacity in the blood of chronic hemodialysis patients.

Key Dates

First listed
Jun 23, 2026
Start date
Oct 31, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
91 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: dialysate composition adjustment
    Four sequential 3-week treatment periods with different dialysate compositions (D-Standard, D-Bic, D-Mag, D-BicMag) in a crossover design.

Primary Outcome Measure

Calciprotein crystallization time (T50) as a measure of mineral buffering capacity [ Time Frame: 3 weeks (per study phase) ]

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