NCT Number: NCT07163936
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at 3, 6, 9, and 12 months
Measurement of total calcium to monitor mineral metabolism and calcium homeostasis.
Time frame: Baseline and at 3, 6, 9, and 12 months
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
Measurement of serum 25-hydroxyvitamin D to evaluate vitamin D status and its potential influence on mineral metabolism.
Time frame: During the 12-month follow-up period
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.
Contact information is provided by the study sponsor or research team.
Francisco Maduell Canals, MD, PhD
CONTACT
(+34)932275400 ext. 5444
Jose Jesus Broseta Monzo, MD, PhD
CONTACT
(+34)932275400 ext. 5444
Hospital Clinic of Barcelona
Other
Acronym: CalCio-HD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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