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Идёт набор NCT05936710

Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate

Без фазы С лечением Intradialytic Hypotension

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: ACETATE based dialysate, CITRATE based dialysate.
Кому может быть актуально
Состояния в реестре: Intradialytic Hypotension. 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
Франция
Следующий шаг
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Официальное название

Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate

Обзор

During intermittent hemodialysis (IHD), the occurrence of intradialytic hemodynamic instability (IHI) is frequent in ICU and impacted morbidity and mortality. Bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. However, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. Recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. They have the appropriate authorizations for routine use. The aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.

Вмешательства

  • Устройство ACETATE based dialysate
    Intermittent hemodialysis with an acetate based dialysate.
  • Устройство CITRATE based dialysate
    Intermittent hemodialysis with an citrate based dialysate.

Первичные конечные точки

  • To show that the use of a citrate-based dialysate decreases the occurrence of intradialytic hypotension in the ICU compared with an acetate-based dialysate (The rate of sessions with occurence of at least one hemodynamic instability (IHI)). [Срок оценки: day 28]
Вторичные конечные точки (12)
  • Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU; [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit. [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital. [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit. [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital. [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h. [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7. [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine. [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation. [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed). [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed). [Срок оценки: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized) [Срок оценки: day 28]

Критерии участия

Критерии включения

  • Patient ≥ 18 years old
  • Patient hospitalized in an intensive care unit
  • Patient with acute renal failure defined by a KDIGO stage ≥ 1 and suspected non-obstructive
  • Patient at risk of per dialytic hypotension (capillary refill time ≥ 3 seconds and/or cardiovascular SOFA ≥ 1 and/or lactatemia > 2mmol/L)
  • Indication for Extra Renal Replacement Therapy with IHD.

Критерии исключения

  • Pregnant or breastfeeding woman
  • Known chronic renal insufficiency of any stage
  • Cardio-renal and hepato renal syndrome
  • Unstable hemodynamic state: refractory shock
  • Patient included in another interventional study likely to modify the hemodynamic state
  • Patient deprived of liberty
  • Patient under guardianship or curatorship
  • Patient not affiliated to a social security system

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
Другое

Центры проведения

Франция · 5 центров
  • Centre Hospitalier Béthune — Béthune
  • CHU — Caen
  • Centre Hospitalier Universitaire de Dijon — Dijon
  • CHRU Nancy — Nancy
  • CHU de ROUEN — Rouen

Идентификаторы

NCT: NCT05936710 · 2023-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗