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

NCT04552821 | Unknown

• 1 other identifier: NKYY_YXKT_IRB_2020_053_01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Title: Study of Biomarkers in Blood and Alveolar Lavage Fluid Samples of Sepsis Patients Complicated With Acute Respiratory Distress Syndrome (ARDS)
2. 2.Research center: Single-center study.
3. 3.Design of the research: A prospective and cohort study.
4. 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. 5.Sample size of the research: Not less than 30 patients in each group.
6. 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. 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. 8.Statistical analysis: Analytical study.
9. 9.The estimated duration of the study：1-2 years.

Conditions

Sepsis; Acute Respiratory Distress Syndrome

Keywords

sepsis; Acute Respiratory Distress Syndrome; metabonomics; biomarkers; oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with ARDS

  an average of 1 year

• Pathway Analysis of the differential metabolites

  12 months

Study Arms (3)

Control

Non-sepsis and non-ARDS adults receiving mechanical ventilation

Sepsis complicated with mild ARDS

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

Patients who meet the criteria of sepsis-3, and also meet the criteria of Berlin diagnostic for moderate/severe ARDS

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with sepsis complicated with ARDS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead

Study Sites (1)

Tianjin NanKai hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (5)

• 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.

  PMID: 32354336 BACKGROUND

• 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.

  PMID: 30779905 BACKGROUND

• Metwaly SM, Winston BW. Systems Biology ARDS Research with a Focus on Metabolomics. Metabolites. 2020 May 19;10(5):207. doi: 10.3390/metabo10050207.

  PMID: 32438561 BACKGROUND

• 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.

  PMID: 20889676 RESULT

• 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.

  PMID: 24289193 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and alveolar lavage fluid were collected from eligible patients within 24 hours after admission to ICU. The blood samples were collected and then placed in a layer at 4°C and centrifuged at 3000×g for 10 minutes. Then the sample were transferred to a cleaning tube and stored in a -80°C refrigerator, waiting for analysis of oxidation and inflammatory indicators.

MeSH Terms

Conditions

Sepsis; Respiratory Distress Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jianbo Yu, MD,PhD

  Tianjin Nankai Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: June 2, 2020
• Primary Completion: June 2, 2024
• Study Completion: July 30, 2024
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)