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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05476029
Enrollment
20
Registered
2022-07-27
Start date
2022-07-25
Completion date
2023-12-30
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis Complicated With ARDS

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.

Detailed description

1. Title: Study on exosomes and biomarkers in plasma and alveolar lavage fluid of patients with sepsis complicated with ARDS 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.

Interventions

DIAGNOSTIC_TESTBlood 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.

Sponsors

Tianjin Nankai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age≥18 years old; 2. Patients with sepsis who meet the criteria for sepsis -3; 3. Agree to participate in this study and sign informed consent;

Exclusion criteria

1. Refuse to participate in this study; 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.

Design outcomes

Primary

MeasureTime frameDescription
Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury1yearDifferential 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.

Countries

China

Contacts

Primary ContactLirong Gong, MD
soundglr@163.com15332039197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026