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- Ensaio Clínico 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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Clermont-Ferrand, França, 63003
- CHU Clermont-Ferrand
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Prazo |
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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
Prazo: 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.
Prazo: 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.
Prazo: 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. -
Prazo: 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 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
Prazo: 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 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
Prazo: 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:
Prazo: 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,
Prazo: on day 1, day 3, and day 6.
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on day 1, day 3, and day 6.
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Ventilação mecânica
- Síndrome do desconforto respiratório agudo (SDRA)
- Unidade de Terapia Intensiva (UTI)
- Lesão pulmonar aguda (LPA)
- Receptor para produtos finais de glicação avançada (RAGE)
- RAGE solúvel (sRAGE)
- Epitélio alveolar
- 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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CHU-0086
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