An interventional study of Citrate dialysate with magensium supplementation and Acetate dialysate in Vascular Calcification, Hemodialysis and Cardiovascular Disease (CKD), sponsored by Hospital Clinic of Barcelona. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Prevention
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.
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's planned enrollment of 80 is above the median of 64 across 56 interventional studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →Hospital Clinic of Barcelona is the lead sponsor of 327 studies on the registry; 55 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fresenius SmartBag 211.5
Device: Acetate dialysate
Fresenius SmartBag CA 211.5-0.75
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.
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.
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.
Time frame: Baseline and at 3, 6, 9, and 12 months
Serum magnesium levels
Measurement of total serum magnesium to assess electrolyte balance and detect hypomagnesemia or hypermagnesemia during the intervention.
Time frame: Baseline and at 3, 6, 9, and 12 months
Total serum calcium levels
Measurement of total calcium to monitor mineral metabolism and calcium homeostasis.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at 3, 6, 9, and 12 months
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.
Time frame: During the 12-month follow-up period
No study locations are listed for this record.
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
Time frame: Data will be available starting from the date of study results publication and will remain accessible indefinitely.
Access criteria: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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