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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetate dialysate | Active Comparator | Fresenius SmartBag 211.5 |
|
| Citrate dialysate | Experimental | Fresenius SmartBag CA 211.5-0.75 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citrate dialysate with magensium supplementation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum magnesium levels | Measurement of total serum magnesium to assess electrolyte balance and detect hypomagnesemia or hypermagnesemia during the intervention. | Baseline and at 3, 6, 9, and 12 months |
| Total serum calcium levels |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the 12-month follow-up period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Jesus Broseta Monzo, MD, PhD | Contact | (+34)932275400 | 5444 | jjbroseta@clinic.cat |
| Francisco Maduell Canals, MD, PhD | Contact | (+34)932275400 | 5444 | fmaduell@clinic.cat |
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IPD including de-identified laboratory results, demographic and clinical variables, and primary and secondary outcome data will be shared. Data will be anonymized to protect patient confidentiality.
Data will be available starting from the date of study results publication and will remain accessible indefinitely.
De-identified individual participant data and supporting documents will be made publicly available on a GitHub repository. Researchers and the public can access and download the data freely without restriction. Data will be anonymized to protect participant confidentiality. Users will be encouraged to cite the original study when using the data.
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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.
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| Acetate dialysate | Device | 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. |
|
Measurement of total calcium to monitor mineral metabolism and calcium homeostasis.
| Baseline and at 3, 6, 9, and 12 months |
| Parathyroid hormone (PTH) levels | Measurement of intact parathyroid hormone to assess bone-mineral metabolism and response to dialysate composition. | Baseline and at 3, 6, 9, and 12 months |
| Serum vitamin D levels | Measurement of serum 25-hydroxyvitamin D to evaluate vitamin D status and its potential influence on mineral metabolism. | Baseline and at 3, 6, 9, and 12 months |
| ID | Term |
|---|---|
| D061205 | Vascular Calcification |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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