Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Calcification propensity (T50 test) [Срок оценки: Baseline and at 3, 6, 9, and 12 months]

Вторичные конечные точки (4)

• Serum magnesium levels [Срок оценки: Baseline and at 3, 6, 9, and 12 months]
• Total serum calcium levels [Срок оценки: Baseline and at 3, 6, 9, and 12 months]
• Parathyroid hormone (PTH) levels [Срок оценки: Baseline and at 3, 6, 9, and 12 months]
• Serum vitamin D levels [Срок оценки: Baseline and at 3, 6, 9, and 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07163936 · HCB/2024/0318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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