Clinical trial NCT05476029: Changes of Exosomes and Biomarkers in Plasma and Alveolar Lavage Fluid of Patients With Sepsis Complicated With ARDS
Official title: Study on Exosomes and Biomarkers in Plasma and Alveolar Lavage Fluid of Patients With Sepsis Complicated With ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis Complicated With ARDS
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sepsis meeting the criteria of sepsis -3 and complicating lung injury

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Plasma and alveolar lavage fluid
state: Tianjin
Study officials:
affiliation: Tianjin Nankai Hospital
name: Jianbo Yu, MD,PhD
role: STUDY_CHAIR
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