Changes of Exosomes and Biomarkers in Plasma and Alveolar Lavage Fluid of Patients With Sepsis Complicated With ARDS
NCT ID: NCT05476029
Last Updated: 2022-07-27
Study Results
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Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2022-07-25
2023-12-30
Brief Summary
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Detailed Description
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2. Research center: monocentric
3. The Design of the study: Randomized, double-blind
4. The population of the study: 1)Age ≥18, no gender or ethnic limitation. 2) Patients with sepsis who meet the criteria of sepsis -3 and ARDS is defined according to Berlin standard.
5. Interventions: Within 24h after admission to ICU, blood samples and alveolar lavage fluid were collected and transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
7\. The aim of the research: to explore the relationship between HO-1, oxidative inflammatory indexes and metabolic indexes and provide an important reference for assisting the management of ARDS disease and predicting the adverse outcomes of sepsis patients with ARDS.
8\. Outcome： Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury, and ho-1, PPARγ or other positive indicators were used to regulate differential miRNAs 9. The estimated duration of the study：2 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sepsis complicated with ARDS group
Blood samples and alveolar lavage fluid were collected within 24h after admission to ICU. After blood samples were collected, they were placed in static stratification at 4°C and centrifuged at 3000×g for 10 min. Serum samples and alveolar lavage fluid samples were transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting, identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
Blood samples and alveolar lavage fluid were collected
Blood samples and alveolar lavage fluid were collected for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
control group
Blood samples and alveolar lavage fluid were collected. After blood samples were collected, they were placed in static stratification at 4°C and centrifuged at 3000×g for 10 min. Serum samples and alveolar lavage fluid samples were transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting, identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
Blood samples and alveolar lavage fluid were collected
Blood samples and alveolar lavage fluid were collected for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
Interventions
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Blood samples and alveolar lavage fluid were collected
Blood samples and alveolar lavage fluid were collected for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
Eligibility Criteria
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Inclusion Criteria
2. Patients with sepsis who meet the criteria for sepsis -3；
3. Agree to participate in this study and sign informed consent；
Exclusion Criteria
2. Patients with left atrial hypertension to prevent the inclusion of patients with abnormal oxygenation index due to cardiogenic pulmonary edema；
3. Pregnant or lactation patients
4. Patients are currently being enrolled in another study
5. The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.
18 Years
ALL
Yes
Sponsors
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Tianjin Nankai Hospital
OTHER
Responsible Party
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Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Principal Investigators
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Jianbo Yu, MD,PhD
Role: STUDY_CHAIR
Tianjin Nankai Hospital
Locations
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Plasma and alveolar lavage fluid
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wang D, Wang X, Si M, Yang J, Sun S, Wu H, Cui S, Qu X, Yu X. Exosome-encapsulated miRNAs contribute to CXCL12/CXCR4-induced liver metastasis of colorectal cancer by enhancing M2 polarization of macrophages. Cancer Lett. 2020 Apr 1;474:36-52. doi: 10.1016/j.canlet.2020.01.005. Epub 2020 Jan 10.
Rezaei R, Baghaei K, Amani D, Piccin A, Hashemi SM, Asadzadeh Aghdaei H, Zali MR. Exosome-mediated delivery of functionally active miRNA-375-3p mimic regulate epithelial mesenchymal transition (EMT) of colon cancer cells. Life Sci. 2021 Mar 15;269:119035. doi: 10.1016/j.lfs.2021.119035. Epub 2021 Jan 13.
Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.
Chekanova JA, Gregory BD, Reverdatto SV, Chen H, Kumar R, Hooker T, Yazaki J, Li P, Skiba N, Peng Q, Alonso J, Brukhin V, Grossniklaus U, Ecker JR, Belostotsky DA. Genome-wide high-resolution mapping of exosome substrates reveals hidden features in the Arabidopsis transcriptome. Cell. 2007 Dec 28;131(7):1340-53. doi: 10.1016/j.cell.2007.10.056.
Wu X, Liu Z, Hu L, Gu W, Zhu L. Exosomes derived from endothelial progenitor cells ameliorate acute lung injury by transferring miR-126. Exp Cell Res. 2018 Sep 1;370(1):13-23. doi: 10.1016/j.yexcr.2018.06.003. Epub 2018 Jun 5.
Zhou Y, Li P, Goodwin AJ, Cook JA, Halushka PV, Chang E, Zingarelli B, Fan H. Exosomes from endothelial progenitor cells improve outcomes of the lipopolysaccharide-induced acute lung injury. Crit Care. 2019 Feb 13;23(1):44. doi: 10.1186/s13054-019-2339-3.
Shin CH, Byun J, Lee K, Kim B, Noh YK, Tran NL, Park K, Kim SH, Kim TH, Oh SJ. Exosomal miRNA-19a and miRNA-614 Induced by Air Pollutants Promote Proinflammatory M1 Macrophage Polarization via Regulation of RORalpha Expression in Human Respiratory Mucosal Microenvironment. J Immunol. 2020 Dec 1;205(11):3179-3190. doi: 10.4049/jimmunol.2000456. Epub 2020 Oct 28.
Zheng L, Su J, Zhang Z, Jiang L, Wei J, Xu X, Lv S. Salidroside regulates inflammatory pathway of alveolar macrophages by influencing the secretion of miRNA-146a exosomes by lung epithelial cells. Sci Rep. 2020 Nov 27;10(1):20750. doi: 10.1038/s41598-020-77448-6.
Other Identifiers
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NKYY_YXKT_IRB_2022_018_01
Identifier Type: -
Identifier Source: org_study_id
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