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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04552821
• Other study ID #: NKYY_YXKT_IRB_2020_053_01
• Status: Active, not recruiting
• Start date: June 2, 2020
• Est. completion date: July 30, 2024

Study information

• Verified date: August 2022
• Source: Tianjin Nankai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 30, 2024
• Est. primary completion date: June 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Syndrome
• Toxemia

Locations

Country	Name	City	State
China	Tianjin NanKai hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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/pr4 — View Citation

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. — View Citation

Metwaly SM, Winston BW. Systems Biology ARDS Research with a Focus on Metabolomics. Metabolites. 2020 May 19;10(5). pii: E207. doi: 10.3390/metabo10050207. Review. — View Citation

Stringer KA, Serkova NJ, Karnovsky A, Guire K, Paine R 3rd, Standiford TJ. Metabolic consequences of sepsis-induced acute lung injury revealed by plasma ¹H-nuclear magnetic resonance quantitative metabolomics and computational analysis. Am J Physiol Lung — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multivariate data analysis of the metabolites	Record the different metabolites between the control group and ARDS patients	an average of 1 year
Primary	Multivariate data analysis of the metabolites	Record the different metabolites between the patient with mild ARDS and with moderate/severe ARDS	12 months
Secondary	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
Secondary	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