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Идёт набор NCT06440759

To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT

Без фазы С лечением AKI - Acute Kidney Injury Pneumonia

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: oXiris filter, M100 filter.
Кому может быть актуально
Состояния в реестре: AKI - Acute Kidney Injury, Pneumonia. 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
Малайзия
Следующий шаг
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Официальное название

Evaluation of Efficacy and Safety Using oXiris Versus M100 Filter in Pneumonia-induced Acute Kidney Injury (AKI) Patients Requiring Continuous Renal Replacement Therapy (CRRT)

Обзор

The purpose of this study aimed to compare the efficacy of Oxiris (Baxter) and M100 filters on IL-6 as primary outcomes and other blood cell counts, blood biochemistry (serum urea, creatinine, potassium, sodium), inflammation indicators (CRP, PCT), as secondary outcomes and safety (28 days mortality as a primary outcome and coagulopathy, lifespan of filter, usage of vasopressor, clinical conditions (ventilator-free days, ICU and hospital- length of stay) as a secondary outcome), clinical conditions (ventilator-free days, ICU and hospital- length of stay), and mortality of patients with pneumonia-related AKI.

Подробное описание

The type of hemofilter will be decided using a simple randomization. For the intervention group, only the oxiris filter will be used during the treatment period, while for the control group, the M100 filter will be used throughout the treatment. If the filter becomes clogged within 24 hours, the investigator will replace it with the same filter as the previous one. However, if the filter becomes clogged after 24 hours and the patient still requires CRRT, the investigator will replace it with M100. This change in filter type will not affect the study results, as only the blood parameters during the first 24 hours of treatment will be evaluated for objective one. The oxiris filter will be used for the first 24 hours, or whichever is longer, and will be replaced with an M100 filter if indicated for both groups. Therefore, it will not affect the outcome of objective two compared to the standard arm group

Termination of CRRT will be done according to recent studies once the patient fulfills either one or more of these criteria: urine output and serum creatinine are indicative of kidney recovery, vasopressor cessation, increased urine output ≥500ml/24H without diuretics, correction of fluid overload, hemodynamic stability and the possible need to shift to intermittent dialysis.

The patient will be followed up until 28 days following ICU admission. To avoid any missing data, at least 3 contact numbers will be made available. If unable to get in contact with the patient, the application status of alive or dead will be applied to a national registry.

Вмешательства

  • Устройство oXiris filter
    Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared.
  • Устройство M100 filter
    Continuous Renal Replacement Therapy with the adsorption membrane filter M100. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared.

Первичные конечные точки

  • To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6 [Срок оценки: 24 hours]
  • To compare the 28-days mortality of using oxiris filter during CRRT [Срок оценки: 28 days]
Вторичные конечные точки (5)
  • To compare the risk infection of by using oxiris during CRRT [Срок оценки: 28 days]
  • To compare the risk bleeding of using oxiris during CRRT [Срок оценки: 28 days]
  • To compare the risk of ventilator-free days of using oxiris during CRRT [Срок оценки: 28 days]
  • To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT [Срок оценки: 24 hours]
  • To measure the effectiveness of the oxiris filter in reducing septic biomarker levels CRP [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • All adult patients aged>18 years old
  • Diagnosis of septic shock
  • Diagnosis of KDIGO stage 3 acute renal failure

Критерии исключения

  • Moribund patient or patient that is expected to die within 72 hours
  • Pregnancy
  • patient with a bleeding tendency or known allergy to heparin

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Малайзия · 1 центр
  • Hospital Universiti Sains Malaysia (HUSM) — Kubang Kerian

Идентификаторы

NCT: NCT06440759 · USM/JEPeM/KK/23090718

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗