- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Clermont-Ferrand, 프랑스, 63003
- CHU clermont-ferrand
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
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
기간: within the first 24 hours after onset of ALI/ARDS
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within the first 24 hours after onset of ALI/ARDS
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
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
기간: 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.
기간: 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.
기간: 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. -
기간: 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
기간: 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
기간: 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:
기간: 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,
기간: on day 1, day 3, and day 6.
|
on day 1, day 3, and day 6.
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
- 기계적 환기
- 급성호흡곤란증후군(ARDS)
- 중환자실(ICU)
- 급성 폐 손상(ALI)
- 최종당화산물(RAGE)에 대한 수용체
- 용해성 RAGE(sRAGE)
- 폐포 상피
- 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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHU-0086
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