End Stage Renal Disease
Conditions
Brief summary
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.
Detailed description
We hypothesize that simultaneously increasing bicarbonate and magnesium concentrations in the dialysate will enhance mineral buffering capacity more effectively than either intervention alone. Ninty-one chronic hemodialysis patients will be enrolled in this randomized, controlled, cross-over study. Using a balanced Latin square design, participants will undergo four sequential 3-week treatment phases with the following dialysates: * D-Standard: 32 mmol/L bicarbonate, 0.5 mmol/L magnesium * D-Bic: 37 mmol/L bicarbonate, 0.5 mmol/L magnesium * D-Mag: 32 mmol/L bicarbonate, 1 mmol/L magnesium * D-BicMag: 37 mmol/L bicarbonate, 1 mmol/L magnesium. The primary endpoint is calciprotein crystallization time (T50); the secondary endpoint is serum levels of endogenous calciprotein particles.
Interventions
OTHERD-Standard
Center's standard dialysate containing 32 mmol/L bicarbonate and 0.5 mmol/L magnesium
OTHERD-Bic
Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium held at 0.5 mmol/L
OTHERD-Mag
Dialysate magnesium increased to 1.0 mmol/L; dialysate bicarbonate held at 32 mmol/L
OTHERD-BicMag
Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium increased to 1.0 mmol/L
Sponsors
Elisabethinen Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Prevalent patients (≥ 3 months) treated with thrice weekly hemodialysis or hemodiafiltration * Dialysate calcium of 1.25 mmol/l
Exclusion criteria
* Inability to provide informed consent * Currently participating in another investigational device or drug study or non-interventional study * Dialysate calcium other than 1.25 mmol/l * Parathyroidectomy planned during the study * Elective living-donor kidney transplant scheduled during the study period * Therapy with bisphosphonates within the past 12 months or denosumab within the past 6 months * Pregnant or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calciprotein crystallization time (T50) as a measure of mineral buffering capacity | 3 weeks (per study phase) | Intra-individual difference in T50 between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endogenous calciprotein particle (CPP) levels | 3 weeks (per study phase) | Intra-individual difference in endogenous calciprotein particle levels between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag) |
Outcome results
None listed