Study of Biomarkers in Patients of Sepsis Complicated With Acute Respiratory Distress Syndrome (ARDS)

Study Overview
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Brief Summary
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Title: Study of Biomarkers in Blood and Alveolar Lavage Fluid Samples of Sepsis Patients Complicated With Acute Respiratory Distress Syndrome (ARDS) Research center: Single-center study. Design of the research: A prospective and cohort study. Object of the research: Patients（age≥18 years）those who meet the diagnostic criteria of sepsis complicated with ARDS and grouped into ARDS group and non-ARDS adults receiving mechanical ventilation as control. Sample size of the research: Not less than 30 patients in each group. Research approach: After admission to ICU, patients who meet the criteria are divided into mild group and moderate/severe group according to the severity of ARDS. In addition, blood and alveolar lavage fluid were collected within 24 hours for metabonomics analysis, and differential metabolites were screened out to prove the differentiation ability of differential metabolites between mild and moderate/severe ARDS patients. Then, MSEA and STITCH analysis were performed, and the relationship between different metabolites, HO-1 protein, oxidative stress and inflammatory markers in serum and alveolar lavage fluid were determined. And whether differential metabolites are associated with 28-day mortality in patients with moderate/severe ARDS. Aim of the research: The metabolomics techniques were used to compare the differences between sepsis patients with mild ARDS and moderate/severe ARDS. And determine the relationship between different metabolites, HO-1 protein, oxidative stress and inflammatory markers, as well as the predictive effect of metabolites on 28-day mortality in patients. Statistical analysis: Analytical study. The estimated duration of the study：1-2 years.

Detailed Description
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This study is a single-center, prospective, retrospective study. In this study, the serum samples and alveolar lavage fluid of patients with sepsis complicated with ARDS were studied by using high performance liquid chromatography (HPLC) tandem electrospray four-stage rod time-of-flight mass spectrometry (LC-ESI-Q-TOF-MS). Aim to screen out the different metabolites between patients with mild and moderate/severe sepsis complicated with ARDS. HO-1 protein, oxidative stress and inflammatory markers in serum and alveolar lavage fluid were measured simultaneously to explore the relationship between HO-1, oxidative inflammatory markers and metabolic markers. In addition, a biomarker model was established to provide an important reference for assisting ARDS disease management and predicting the adverse outcome of patients with sepsis complicated with ARDS.

Official Title
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Study of Biomarkers in Blood and Alveolar Lavage Fluid Samples of Sepsis Patients Complicated With Acute Respiratory Distress Syndrome (ARDS)

Conditions
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Sepsis, Acute Respiratory Distress Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Patients with sepsis who meet the criteria for sepsis -3 Patients complicated with Acute Respiratory Distress Syndrome who meet the Berlin diagnostic criteria Agree to participate in this study and sign informed consent Exclusion Criteria: Refuse to participate in this study Patient with HIV infection, patients in pregnancy or breast stage Patient had chronic respiratory ailments Patients are now being included in another study In the opinion of the attending physician or researcher, there are other conditions that are not appropriate for the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Non-sepsis and non-ARDS adults receiving mechanical ventilation | |
| Sepsis complicated with mild ARDS<br>Patients who meet the criteria of sepsis-3, and also meet the criteria of Berlin diagnostic for mild ARDS | |
| Sepsis complicated with moderate/severe ARDS<br>Patients who meet the criteria of sepsis-3, and also meet the criteria of Berlin diagnostic for moderate/severe ARDS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multivariate data analysis of the metabolites | Record the different metabolites between the control group and ARDS patients | an average of 1 year | 
| Multivariate data analysis of the metabolites | Record the different metabolites between the patient with mild ARDS and with moderate/severe ARDS | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with ARDS | Investigated the metabolites to distinguish the non-survivors from the survivors of sepsis complicated with ARDS | an average of 1 year | 
| Pathway Analysis of the differential metabolites | Screened the differential metabolism pathway between mild ARDS and with moderate/severe ARDS, and screened the differential metabolism pathway between non-survivors and survivors | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, Acute Respiratory Distress Syndrome, metabonomics, biomarkers, oxidative stress, Inflammation