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Status unknownNCT04552821Updated Aug 4, 2022

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

An observational study in Sepsis and Acute Respiratory Distress Syndrome, sponsored by Tianjin Nankai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Tianjin Nankai Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed 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.

02

Conditions studied

  • Sepsis
  • Acute Respiratory Distress Syndrome

Keywords

  • sepsis
  • Acute Respiratory Distress Syndrome
  • metabonomics
  • biomarkers
  • oxidative stress
  • Inflammation
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 90 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Tianjin Nankai Hospital is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with sepsis complicated with ARDS

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Multivariate data analysis of the metabolites

    Record the different metabolites between the control group and ARDS patients

    Time frame: an average of 1 year

  2. Multivariate data analysis of the metabolites

    Record the different metabolites between the patient with mild ARDS and with moderate/severe ARDS

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: an average of 1 year

  2. 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

    Time frame: 12 months

07

Study locations

1 site
  • Tianjin NanKai hospital
    Tianjin, Tianjin, China
08

References and documents

Publications

  • 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. PubMed 32354336 ↗
  • 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. PubMed 30779905 ↗
  • Metwaly SM, Winston BW. Systems Biology ARDS Research with a Focus on Metabolomics. Metabolites. 2020 May 19;10(5):207. doi: 10.3390/metabo10050207. PubMed 32438561 ↗
  • 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. PubMed 20889676 ↗
  • 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. PubMed 24289193 ↗

Individual participant data

Plan to share: No — All of the individual participant data collected during the trial,after deidentification will be shared.And anyone who wishes to acess the date will be available for any purpose.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04552821
Lead sponsor
Tianjin Nankai Hospital
Responsible party
Jianbo Yu (Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor, Tianjin Nankai Hospital) — Principal investigator
First posted
Sep 17, 2020
Start date
Jun 2, 2020
Primary completion
Jun 2, 2024 (estimated)
Completion
Jul 30, 2024 (estimated)
Last update
Aug 4, 2022

Study contacts

Jianbo Yu, MD,PhD
study chair · Tianjin Nankai Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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