Cardiovascular Disease (CKD), Hemodialysis, Vascular Calcification
Conditions
Keywords
hemodialysis, dialysate, citrate dialysate, acetate dialysate, magnesium supplementation, calcification propensity, vascular calcification, dialysate composition
Brief summary
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
DEVICECitrate 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.
DEVICEAcetate 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.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a prospective, randomized, open-label, single-center clinical trial with 12 months of follow-up. Participants will be randomly assigned in a 1:1 ratio to one of two study arms: Control group: Hemodialysis with acetate-based dialysate (Fresenius SmartBag 211.5) Intervention group: Hemodialysis with citrate-based dialysate containing magnesium supplementation (Fresenius SmartBag CA 211.5-0.75) Both dialysates are routinely used in clinical practice.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcification propensity (T50 test) | Baseline and at 3, 6, 9, and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum magnesium levels | Baseline and at 3, 6, 9, and 12 months | Measurement of total serum magnesium to assess electrolyte balance and detect hypomagnesemia or hypermagnesemia during the intervention. |
| Total serum calcium levels | Baseline and at 3, 6, 9, and 12 months | Measurement of total calcium to monitor mineral metabolism and calcium homeostasis. |
| Parathyroid hormone (PTH) levels | Baseline and at 3, 6, 9, and 12 months | Measurement of intact parathyroid hormone to assess bone-mineral metabolism and response to dialysate composition. |
| Serum vitamin D levels | Baseline and at 3, 6, 9, and 12 months | Measurement of serum 25-hydroxyvitamin D to evaluate vitamin D status and its potential influence on mineral metabolism. |
Contacts
CONTACTJose Jesus Broseta Monzo, MD, PhD
CONTACTFrancisco Maduell Canals, MD, PhD
Outcome results
None listed