- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05101694
Study on the Correlation Between Alveolar Macrophage-derived Autophagosomes and the Severity of Lung Injury in ARDS
연구 개요
상태
정황
상세 설명
Nowadays, acute respiratory distress syndrome (ARDS) is a major clinical problem in the world. Infection and other factors induce immune cells to release inflammatory mediators, and the following uncontrolled inflammatory response is the fundamental reason for the poor prognosis of ARDS. So, it's important to explore the mechanism of ARDS and reduce lung injury.
In the lung tissue, the activation of alveolar macrophages (including alveolar resident macrophages and macrophages recruited in the blood) is an important way that mediates the ARDS inflammatory response. The previous study of the investigator's team proved that alveolar macrophages could not only directly secrete inflammatory mediators, but also mediated the release of inflammatory factors through the secretion of autophagosomes. At the same time, ARDS has been extensively studied in molecular biology, but the prospective exploration of the relationship between the host response and the development mechanism of ARDS is lacking.
The formation of autophagosomes is the marker of autophagy. In the process of ARDS, alveolar macrophages can secrete a large number of autophagosomes to mediate the inflammatory response of ARDS and aggravate the pathological damage of the lungs. At the same time, the meta-transcriptome can detect the expression of all genes without a reference genome, so it has an irreplaceable advantage in exploring the host's response when pathogenic microorganisms invade the body. The investigators speculate that there may be differences in the host response between patients with different types of ARDS.
However, the above results are derived from cell or animal experiments. It hasn't been known whether autophagosomes could be secreted in the alveoli of ARDS patients, and it has not been proven that whether there is a difference in host response between ARDS patients and controls. Therefore, this study intends to explore that Whether the alveoli macrophage-derived autophagosomes are related to the severity and prognosis of ARDS, and try to construct a recognition model to predict the prognosis of ARDS.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Dong Xuecheng, bachelor
- 전화번호: 15850501101
- 이메일: xuechengdong2020@163.com
연구 장소
-
-
Jiangsu
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Nanjing, Jiangsu, 중국, 210009
- 모병
- Nanjing Zhong-Da Hospital, Southeast University
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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:
- Age 18-85 years old
- Meet ARDS Berlin diagnostic criteria
- Artificial airway has been established (tracheal intubation, tracheotomy)
- Sign informed consent
- Within 7 days of diagnosis of ARDS
Exclusion Criteria:
- Younger than 18 years old or older than 85 years old
- Pregnant women, cancer and immune system diseases
- There are contraindications for bronchoscopy (poor oxygenation/severe heart disease, cardiac insufficiency/abnormal blood clotting, massive hemoptysis/aortic aneurysm risk of rupture, etc.)
- Patients undergoing other clinical trials
- Estimated survival time <24h
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The link between the proportion of macrophage-derived autophagosomes in alveolar lavage fluid of ARDS patients with the severity of ARDS
기간: at the first day of enrolling the patients
|
Getting these data through Flow cytometer and analyzing the link between these data with the severity of ARDS
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at the first day of enrolling the patients
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Autophagosomes in alveolar lavage fluid of ARDS patients with the prognosis of ARDS
기간: at the twenty-eighth day of enrolling the patients
|
Getting these data through Flow cytometer and analyzing the link between these data with the prognosis of ARDS
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at the twenty-eighth day of enrolling the patients
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Autophagosomes and macrophage-derived autophagosomes in blood
기간: day 1,day 3 or day 7
|
Getting these data through Flow cytometer and analyzing the link between these data with the prognosis of ARDS
|
day 1,day 3 or day 7
|
extracellular vesicles
기간: day 1,day 3 or day 7
|
extracellular vesicles in alveolar lavage fluid and blood through Flow cytometer
|
day 1,day 3 or day 7
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Mortality
기간: During hospitalization
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ICU, 28 day and hospital mortality
|
During hospitalization
|
length of stay
기간: During hospitalization
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ICU and hospital length of stay
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During hospitalization
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Ling Liu, Dr, Southeast university
간행물 및 유용한 링크
일반 간행물
- Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
- Irish Critical Care Trials Group. Acute lung injury and the acute respiratory distress syndrome in Ireland: a prospective audit of epidemiology and management. Crit Care. 2008;12(1):R30. doi: 10.1186/cc6808. Epub 2008 Feb 29.
- Liu L, Yang Y, Gao Z, Li M, Mu X, Ma X, Li G, Sun W, Wang X, Gu Q, Zheng R, Zhao H, Ao D, Yu W, Wang Y, Chen K, Yan J, Li J, Cai G, Wang Y, Wang H, Kang Y, Slutsky AS, Liu S, Xie J, Qiu H. Practice of diagnosis and management of acute respiratory distress syndrome in mainland China: a cross-sectional study. J Thorac Dis. 2018 Sep;10(9):5394-5404. doi: 10.21037/jtd.2018.08.137.
- Sakr Y, Francois B, Sole-Violan J, Kotfis K, Jaschinski U, Estella A, Leone M, Jakob SM, Wittebole X, Fontes LE, de Melo Gurgel M, Midega T, Vincent JL, Ranieri VM; SOAP and ICON Investigators. Temporal changes in the epidemiology, management, and outcome from acute respiratory distress syndrome in European intensive care units: a comparison of two large cohorts. Crit Care. 2021 Feb 25;25(1):87. doi: 10.1186/s13054-020-03455-8.
- Pourfathi M, Kadlecek SJ, Chatterjee S, Rizi RR. Metabolic Imaging and Biological Assessment: Platforms to Evaluate Acute Lung Injury and Inflammation. Front Physiol. 2020 Aug 31;11:937. doi: 10.3389/fphys.2020.00937. eCollection 2020.
- Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available.
- Huang X, Xiu H, Zhang S, Zhang G. The Role of Macrophages in the Pathogenesis of ALI/ARDS. Mediators Inflamm. 2018 May 13;2018:1264913. doi: 10.1155/2018/1264913. eCollection 2018.
- Dikic I, Elazar Z. Mechanism and medical implications of mammalian autophagy. Nat Rev Mol Cell Biol. 2018 Jun;19(6):349-364. doi: 10.1038/s41580-018-0003-4.
- Mizushima N, Levine B. Autophagy in Human Diseases. N Engl J Med. 2020 Oct 15;383(16):1564-1576. doi: 10.1056/NEJMra2022774. No abstract available.
- Wang J, Davis S, Zhu M, Miller EA, Ferro-Novick S. Autophagosome formation: Where the secretory and autophagy pathways meet. Autophagy. 2017 May 4;13(5):973-974. doi: 10.1080/15548627.2017.1287657. Epub 2017 Feb 15.
- Gonzalez CD, Resnik R, Vaccaro MI. Secretory Autophagy and Its Relevance in Metabolic and Degenerative Disease. Front Endocrinol (Lausanne). 2020 May 5;11:266. doi: 10.3389/fendo.2020.00266. eCollection 2020.
- Davis S, Wang J, Ferro-Novick S. Crosstalk between the Secretory and Autophagy Pathways Regulates Autophagosome Formation. Dev Cell. 2017 Apr 10;41(1):23-32. doi: 10.1016/j.devcel.2017.03.015.
- Bel S, Pendse M, Wang Y, Li Y, Ruhn KA, Hassell B, Leal T, Winter SE, Xavier RJ, Hooper LV. Paneth cells secrete lysozyme via secretory autophagy during bacterial infection of the intestine. Science. 2017 Sep 8;357(6355):1047-1052. doi: 10.1126/science.aal4677. Epub 2017 Jul 27.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2021ZDSYLL215-P01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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