Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Citrate dialysate with magensium supplementation, Acetate dialysate.
- Who it may be relevant to
- Registry conditions: Vascular Calcification, Hemodialysis, Cardiovascular Disease (CKD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
Vascular calcification is a common and serious complication in patients receiving long-term hemodialysis. Dialysate composition may influence its progression. Acetate, a weak acid, has traditionally been added to dialysate to maintain chemical stability and prevent precipitation of calcium or magnesium bicarbonate salts. However, long-term acetate exposure has been associated with adverse effects, prompting the search for safer alternatives.
Citrate is a promising substitute that may help reduce vascular calcification by maintaining a neutral calcium balance. Nevertheless, it can lower magnesium levels in the blood (hypomagnesemia), which might counteract its benefits. This supports the idea of adding magnesium to citrate-based dialysate.
This is a prospective, randomized, open-label clinical trial designed to compare the effects of acetate-based dialysate versus citrate-based dialysate with magnesium supplementation in adult hemodialysis patients. Participants will be enrolled and followed for 12 months.
The primary outcome will be changes in calcification propensity (T50). Secondary outcomes include changes in serum magnesium, calcium, and PTH levels, as well as the incidence of cardiovascular events and all-cause mortality.
The findings may help identify a safer and more effective dialysate composition to improve cardiovascular outcomes in this patient population.
Interventions
- Device Citrate dialysate with magensium supplementation
Citrate-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. - Device Acetate dialysate
Acetate-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.
Primary outcome measures
- Calcification propensity (T50 test) [Time frame: Baseline and at 3, 6, 9, and 12 months]
Secondary outcome measures (4)
- Serum magnesium levels [Time frame: Baseline and at 3, 6, 9, and 12 months]
- Total serum calcium levels [Time frame: Baseline and at 3, 6, 9, and 12 months]
- Parathyroid hormone (PTH) levels [Time frame: Baseline and at 3, 6, 9, and 12 months]
- Serum vitamin D levels [Time frame: Baseline and at 3, 6, 9, and 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
- Severe hypocalcemia or poorly controlled secondary hyperparathyroidism
- Any condition that, in the investigator's judgment, contraindicates participation or affects study compliance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07163936 · HCB/2024/0318