Идёт набор NCT07123909

Studies on Adsorption International Learning Initiative Global

Без фазы С лечением CKD (Chronic Kidney Disease) Stage 5D Uremia; Chronic Uremic; Toxemia Inflammation Chronic

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: Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material..
Кому может быть актуально: Состояния в реестре: CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic, Uremic; Toxemia, Inflammation Chronic. 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: Россия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Use of Sorption Technologies in Patients Receiving Program Hemodialysis With Inflammatory Syndrome

Обзор

Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia

Подробное описание

This study will involve 30 hemodialysis patients selected based on examination results showing elevated C-reactive protein (CRP) and/or interleukin-6 (IL-6) levels. Participants will undergo hemoadsorption with the Jafron HA130 cartridge performed concurrently with hemodialysis: three times per week during the first month, twice per week during the second month, and once per week during the third month.

The following parameters will be assessed: inflammatory markers (CRP, IL-1, IL-6, IL-8, β2-microglobulin, free light chains of immunoglobulins), parathyroid hormone (PTH), standard biochemical blood tests (creatinine, urea, calcium, phosphorus, albumin, iron metabolism), and complete blood count. Analyses will be performed at baseline (before inclusion) and monthly thereafter.

Вмешательства

Устройство Patients will undergo a combined hemodialysis and hemosorption procedure. The study cartridge for hemosorption by Jafron HA130 contains the original adsorbing material.
The test cartridge will be used in addition to the ongoing program hemodialysis three times a week in the first month, twice a week in the next month, once a week in the third month

Первичные конечные точки

Change from baseline in serum IL-6, pg/ml [Срок оценки: By the third month]

Вторичные конечные точки (12)

Change frome baseline in serum IL-1, pg/ml [Срок оценки: Monthly for 3 months]
Change from baseline in serum IL-8, pg/ml [Срок оценки: Monthly for 3 months]
Change from baseline in serum IL-10, pg/ml [Срок оценки: Monthly for 3 months]
Change from baseline in CRP, mg/L [Срок оценки: Monthly for 3 months]
Change from baseline in β2-microglobulin, mg/L [Срок оценки: Monthly for 3 months]
Change from baseline in free light chains, mcg/ml [Срок оценки: Monthly for 3 months]
Change from baseline in PTH, pg/ml [Срок оценки: Monthly for 3 months]
Change from baseline in serum iron, mcg/dL [Срок оценки: Monthly for 3 months]
Change from baseline in ferritin, mcg/L [Срок оценки: Monthly for 3 months]
Change from baseline in saturated transferrin, TS% [Срок оценки: Monthly for 3 months]
Change from baseline in albumin, g/L [Срок оценки: Monthly for 3 months]
Change from baseline in phosphorus, mmol/L [Срок оценки: Monthly for 3 months]

Критерии участия

Критерии включения

Adequate dialysis defined by a KT/V index ≥ 1.4
No active inflammatory process or infection
Age ≥ 18 years
Receiving standard hemodialysis regimen three times weekly, at least 4 hours per session
Participants with elevated interleukin-6 (IL-6) and/or C-reactive protein (CRP) levels exceeding local laboratory reference values