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

July 24, 2022 updated by: Jianbo Yu, Tianjin Nankai Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300100
        • Recruiting
        • Plasma and alveolar lavage fluid
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury
Time Frame: 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.
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Nankai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 25, 2022

Primary Completion (ANTICIPATED)

May 30, 2023

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (ACTUAL)

July 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 24, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKYY_YXKT_IRB_2022_018_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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