- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01270295
Soluble Forms and Ligands of RAGE in ALI/ARDS (SoLiRAGE). (SoLiRAGE)
Soluble Forms and Ligands of the Receptor for Advanced Glycation End Products (RAGE) in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS : an Observational Prospective Study.
Обзор исследования
Статус
Подробное описание
BACKGROUND:
The receptor for advanced glycation end products (RAGE) is now identified as a marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor and is involved in propagating inflammatory responses. While the precise function of RAGE remains unclear, the elevated levels of RAGE, and its soluble isoform sRAGE, correlate with severity of ALI/ARDS in human and animal studies, and RAGE levels could reflect impaired alveolar fluid clearance. Frequently, the biology of RAGE coincides with settings in which ligands of the receptor accumulate, especially in a proinflammatory environment. More work is needed for us to understand the mechanisms by which RAGE is regulated during ALI/ARDS, especially with regard to the expression of its soluble forms and the involvement of its potential ligands.
DESIGN NARRATIVE:
This observational prospective clinical study will describe and compare soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in the alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours after onset of ALI/ARDS, and from patients under mechanical ventilation (control group).
Edema fluid and plasma samples will be collected simultaneously on day 1, day 3 and day 6, in order to describe kinetics of evolution of soluble forms and ligands of RAGE levels. Undiluted pulmonary edema fluid samples will be collected in intubated patients only, and blood samples will be simultaneously gathered from indwelling arterial and central venous catheters. The concentrations of soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) will be measured in duplicate by ELISA.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Clermont-Ferrand, Франция, 63003
- CHU Clermont-Ferrand
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- ICU patients under mechanical ventilation
- Patients within the first 24 hours after onset of ALI/ARDS according to the 1994 American-European Consensus Conference (AECC)
Exclusion Criteria:
- Pregnancy
- Acute exacerbation of diabetes
- Dialysis for end-stage kidney disease
- Alzheimer's disease
- Amyloidosis
- Evolutive neoplastic lesion
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in the plasma from ICU patients within the first 24 hours after onset of ALI/ARDS
Временное ограничение: within the first 24 hours after onset of ALI/ARDS
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within the first 24 hours after onset of ALI/ARDS
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
To describe kinetics of evolution of soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with or without ALI/ARDS: biomarkers levels in pulmonary edema fluid and plasma on day 1, day 3, and day 6
Временное ограничение: on day 1, day 3, and day 6
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on day 1, day 3, and day 6
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To describe the plasma and pulmonary levels of soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) in the setting of ALI/ARDS.
Временное ограничение: on day 1, day 3, and day 6.
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on day 1, day 3, and day 6.
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To test the correlation between soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels and net alveolar fluid clearance in patients within the first 24 hours after onset of ALI/ARDS.
Временное ограничение: within the first 24 hours after onset of ALI/ARDS
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within the first 24 hours after onset of ALI/ARDS
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To decribe venous-to-arterial differences in soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels during ALI/ARDS. -
Временное ограничение: on day 1, day 3, and day 6.
|
on day 1, day 3, and day 6.
|
To test the correlation between biomarkers levels (soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs)) and CT-scan lung morphology in patients within the first 24 hours after onset of ALI/ARDS
Временное ограничение: within the first 24 hours after onset of ALI/ARDS
|
within the first 24 hours after onset of ALI/ARDS
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To describe soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients under mechanical ventilation (MV), in order to assess the influence of MV on these markers: biomarkers levels in pulmonary edema fluid and plasma
Временное ограничение: on day 1, day 3, and day 6
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on day 1, day 3, and day 6
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To test the prognostic value of soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with ALI/ARDS:
Временное ограничение: on day 28
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on day 28
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To test the correlation between biomarkers levels (soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1,
Временное ограничение: on day 1, day 3, and day 6.
|
on day 1, day 3, and day 6.
|
Соавторы и исследователи
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
- Механическая вентиляция
- Острый респираторный дистресс-синдром (ОРДС)
- Отделение интенсивной терапии (ОИТ)
- Острое повреждение легких (ALI)
- Рецептор конечных продуктов гликирования (RAGE)
- Растворимый RAGE (sRAGE)
- Альвеолярный эпителий
- Endogenous secretory RAGE (esRAGE)
- High-mobility group box-1 protein (HMGB-1)
- Extracellular newly-identified RAGE-binding protein (EN-RAGE or S100A12)
- Advanced glycation endproducts (AGEs)
- Pentosidine
- N--carboxymethyllysine
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CHU-0086
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