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

• Conditions: Sepsis Complicated With ARDS
• Interventions: Diagnostic Test: Blood samples and alveolar lavage fluid were collected

• Registration Number: NCT05476029
• Lead Sponsor: Tianjin Nankai Hospital

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-24
• Last Update Submitted: 2022-07-24
• Study Start: 2022-07-25
• Study First Posted: 2022-07-27
• Last Update Posted: 2022-07-27
• Primary Completion: 2023-05-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis complicated with ARDS group	Blood samples and alveolar lavage fluid were collected	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.
control group	Blood samples and alveolar lavage fluid were collected	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.

Primary Outcome Measures

Name	Time	Method
Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury	1year	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.

Trial Locations

Locations (1)

Plasma and alveolar lavage fluid; 🇨🇳 Tianjin, Tianjin, China