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Идёт набор NCT07206524

Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation

Без фазы С лечением Hemodialysis Thromboinflammation Hemodialysis Complication End Stage Renal Disease (ESRD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L, Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L, Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L.
Кому может быть актуально
Состояния в реестре: Hemodialysis, Thromboinflammation, Hemodialysis Complication, End Stage Renal Disease (ESRD). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
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Официальное название

Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial

Обзор

This clinical trial investigates whether the composition of dialysate influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of magnesium concentration and acid type in dialysate on immune cell activation and thromboinflammatory responses. Patients participating to the multicentric pilot OMAGOD trial will be invited to participate to this monocentric plus study. In the pilot OMAGOD trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialysate compositions in a crossover design. Each treatment phase lasts two weeks (six sessions). For the local plus study, during selected sessions (3 per patient - midweek hemodialysis session of the last week of a treatment period), blood samples will be collected (at baseline, hourly, and at the end of dialysis) and additionally, after each session, the used dialysis circuit will be rinsed to recover adherent cells. The study aims to: * Assess whether the dialysate composition influences leukocyte and platelet activation . * Evaluate whether the dialysate composition influences neutrophil extracellular trap (NET) formation. * Identify novel biomarkers of thromboinflammation using transcriptomic analysis of immune cells.

Вмешательства

  • Другое Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L
    Change dialysate compositions being used during hemodialysis treatment in each arm.
  • Другое Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L
    Standard dialysate containing acetic acid and magnesium at a concentration of 0.5 mmol/L, used during hemodialysis sessions.
  • Другое Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L
    Dialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions.

Первичные конечные точки

  • Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition [Срок оценки: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)]
Вторичные конечные точки (4)
  • differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition [Срок оценки: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)]
  • Differences in leukocyte and platelet activation markers in blood and rinse fluid samples of discarded hemodialysis circuits measured by flow cytometry in relation to dialysate composition [Срок оценки: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)]
  • Differences in coagulation activation and inflammatory biomarkers measured by multiplex-based immunoassays in relation to dialysate composition [Срок оценки: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)]
  • Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition [Срок оценки: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)]

Критерии участия

Критерии включения

  • Participants to the OMAGOD pilot trial

Критерии исключения

  • Patients who are not participating in the OMAGOD pilot trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Бельгия · 1 центр
  • Universitair Ziekenhuis Brussel — Brussels

Идентификаторы

NCT: NCT07206524 · 25113_PILOTOMAGOD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗