Study of Biomarkers in Patients of Sepsis Complicated With Acute Respiratory Distress Syndrome (ARDS)
NCT ID: NCT04552821
Last Updated: 2022-08-04
Study Results
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Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2020-06-02
2024-07-30
Brief Summary
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2. Research center: Single-center study.
3. Design of the research: A prospective and cohort study.
4. 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.
5. Sample size of the research: Not less than 30 patients in each group.
6. 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.
7. 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.
8. Statistical analysis: Analytical study.
9. The estimated duration of the study：1-2 years.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control
Non-sepsis and non-ARDS adults receiving mechanical ventilation
No interventions assigned to this group
Sepsis complicated with mild ARDS
Patients who meet the criteria of sepsis-3, and also meet the criteria of Berlin diagnostic for mild ARDS
No interventions assigned to this group
Sepsis complicated with moderate/severe ARDS
Patients who meet the criteria of sepsis-3, and also meet the criteria of Berlin diagnostic for moderate/severe ARDS
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tianjin Nankai Hospital
OTHER
Responsible Party
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Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Principal Investigators
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Jianbo Yu, MD,PhD
Role: STUDY_CHAIR
Tianjin Nankai Hospital
Locations
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Tianjin NanKai hospital
Tianjin, Tianjin Municipality, China
Countries
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References
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Xu J, Pan T, Qi X, Tan R, Wang X, Liu Z, Tao Z, Qu H, Zhang Y, Chen H, Wang Y, Zhang J, Wang J, Liu J. Increased mortality of acute respiratory distress syndrome was associated with high levels of plasma phenylalanine. Respir Res. 2020 Apr 30;21(1):99. doi: 10.1186/s12931-020-01364-6.
Lin S, Yue X, Wu H, Han TL, Zhu J, Wang C, Lei M, Zhang M, Liu Q, Xu F. Explore potential plasma biomarkers of acute respiratory distress syndrome (ARDS) using GC-MS metabolomics analysis. Clin Biochem. 2019 Apr;66:49-56. doi: 10.1016/j.clinbiochem.2019.02.009. Epub 2019 Feb 16.
Metwaly SM, Winston BW. Systems Biology ARDS Research with a Focus on Metabolomics. Metabolites. 2020 May 19;10(5):207. doi: 10.3390/metabo10050207.
Stringer KA, Serkova NJ, Karnovsky A, Guire K, Paine R 3rd, Standiford TJ. Metabolic consequences of sepsis-induced acute lung injury revealed by plasma (1)H-nuclear magnetic resonance quantitative metabolomics and computational analysis. Am J Physiol Lung Cell Mol Physiol. 2011 Jan;300(1):L4-L11. doi: 10.1152/ajplung.00231.2010. Epub 2010 Oct 1.
Evans CR, Karnovsky A, Kovach MA, Standiford TJ, Burant CF, Stringer KA. Untargeted LC-MS metabolomics of bronchoalveolar lavage fluid differentiates acute respiratory distress syndrome from health. J Proteome Res. 2014 Feb 7;13(2):640-9. doi: 10.1021/pr4007624. Epub 2013 Dec 9.
Other Identifiers
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NKYY_YXKT_IRB_2020_053_01
Identifier Type: -
Identifier Source: org_study_id
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