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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dialysate composition adjustment | Experimental | Four sequential 3-week treatment periods with different dialysate compositions (D-Standard, D-Bic, D-Mag, D-BicMag) in a crossover design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Standard | Other | Center's standard dialysate containing 32 mmol/L bicarbonate and 0.5 mmol/L magnesium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calciprotein crystallization time (T50) as a measure of mineral buffering capacity | Intra-individual difference in T50 between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag) | 3 weeks (per study phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous calciprotein particle (CPP) levels | 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) | 3 weeks (per study phase) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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 |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |