The goal of this clinical trial is to find out if using a citrate-based dialysate with added magnesium during hemodialysis can help slow down or prevent the hardening of blood vessels (vascular calcification) in adults on long-term dialysis.
The main questions the study will try to answer are:
Does citrate-based dialysate with magnesium improve the blood's ability to prevent calcium buildup (measured by a test called T50) compared to acetate-based dialysate?
Does it modify magnesium, calcium and parathyroid hormone (PTH) levels in the blood?
Does it lower the chances of heart problems or death?
Researchers will compare two groups: one will receive acetate-based dialysate, and the other will receive citrate-based dialysate with magnesium.
Participants will:
Receive one of the two types of dialysate during their regular hemodialysis sessions for 12 months
Have regular blood tests
Be monitored for any heart problems and for overall health during the study
Adults (≥18 years old) on maintenance hemodialysis for more than 3 months
Clinically stable patients with a well-functioning vascular access
Residual urine output ≤ 250 mL/day
Able and willing to provide written informed consent
Known allergy or intolerance to any component of the dialysates
Active malignancy or infectious/inflammatory disease
Planned living donor kidney transplant before study completion
Current treatment with vitamin K antagonists (coumarins)
Parallel
Citrate dialysate with magensium supplementation
DeviceCitrate-based bicarbonate dialysate containing: sodium 138 mmol/L, chloride 110 mmol/L, potassium 2 mmol/L, calcium 1.5 mmol/L, magnesium 0.75 mmol/L, citrate 1 mmol/L, glucose 1 g/L, bicarbonate 32 mmol/L.
Acetate dialysate
DeviceAcetate-based bicarbonate dialysate containing: sodium 138 mmol/L, chloride 109 mmol/L, potassium 2 mmol/L, calcium 1.5 mmol/L, magnesium 0.5 mmol/L, acetate 3 mmol/L, glucose 1 g/L, bicarbonate 32 mmol/L.
Calcification propensity (T50 test)
T50 is a laboratory test that measures the serum's intrinsic capacity to inhibit calcium-phosphate precipitation, reflecting the overall propensity for vascular and soft tissue calcification. Higher T50 values indicate greater calcification resistance.
Serum magnesium levels
Measurement of total serum magnesium to assess electrolyte balance and detect hypomagnesemia or hypermagnesemia during the intervention.
Total serum calcium levels
Measurement of total calcium to monitor mineral metabolism and calcium homeostasis.
Parathyroid hormone (PTH) levels
Measurement of intact parathyroid hormone to assess bone-mineral metabolism and response to dialysate composition.
Serum vitamin D levels
Measurement of serum 25-hydroxyvitamin D to evaluate vitamin D status and its potential influence on mineral metabolism.
Cardiovascular events and all-cause mortality
Number and type of cardiovascular events, including myocardial infarction, stroke, heart failure, and hospitalization due to cardiovascular causes, as well as number of deaths from any cause during the study period.
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This trial is not recruiting at the moment. You can still explore other options:
