Changes of Exosomes and Biomarkers in Plasma and Alveolar Lavage Fluid of Patients With Sepsis Complicated With ARDS

NCT05476029 | Unknown

• 1 other identifier: NKYY_YXKT_IRB_2022_018_01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, serum samples and alveolar lavage fluid from patients with sepsis complicated with ARDS were studied. The differential miRNAs of inflammatory exosomes in patients with sepsis lung injury were screened, and Sestrin2, HO-1 and PPARγ proteins, oxidative stress and inflammatory indexes in serum and alveolar lavage fluid were measured simultaneously, to explore the relationship between HO-1, oxidative inflammatory indexes and metabolic indexes. These results provide an important reference for assisting the management of ARDS disease and predicting the adverse outcomes of sepsis patients with ARDS.

Conditions

Sepsis Complicated With ARDS

Outcome Measures

Primary Outcomes (1)

• Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury

  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.

  1year

Study Arms (2)

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.

Diagnostic Test: Blood samples and alveolar lavage fluid were collected

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.

Diagnostic Test: Blood samples and alveolar lavage fluid were collected

Interventions

Blood samples and alveolar lavage fluid were collected DIAGNOSTIC_TEST

Blood samples and alveolar lavage fluid were collected for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.

Sepsis complicated with ARDS group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sepsis meeting the criteria of sepsis -3 and complicating lung injury

You may qualify if:

• Age≥18 years old；
• Patients with sepsis who meet the criteria for sepsis -3；
• Agree to participate in this study and sign informed consent；

You may not qualify if:

• Refuse to participate in this study；
• Pregnant or lactation patients
• Patients are currently being enrolled in another study
• The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead

Study Sites (1)

Plasma and alveolar lavage fluid

Tianjin, Tianjin Municipality, 300100, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 31931030 RESULT

• 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.

  PMID: 33450254 RESULT

• Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.

  PMID: 32029601 RESULT

• 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.

  PMID: 18160042 RESULT

• 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.

  PMID: 29883714 RESULT

• 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.

  PMID: 30760290 RESULT

• 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.

  PMID: 33115854 RESULT

• 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.

  PMID: 33247202 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jianbo Yu, MD,PhD

  Tianjin Nankai Hospital

  STUDY CHAIR

Central Study Contacts

Lirong Gong, MD

CONTACT

15332039197; soundglr@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 27, 2022
• Study Start: July 25, 2022
• Primary Completion: May 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)