Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)

March 23, 2020 updated by: Mingdong Hu
The aim of the investigators 'study is to investigate the relationship between the biomarkers (e.g. protein markers, genetic polymorphisms and epigenetic markers) and the onset of ARDS. In this study, the participants were divided into case group (with ARDS) and control group (without ARDS), based on a nested case-control study method. During the diagnosis and treatment, the clinical data of subjects are collected at the given time point. And the clinical data are extracted from plasma, blood and bronchoalveolar lavage fluid of participants. These data will be analyzed based on statistical methods. In the end ,the investigators can build a multi index early warning model based on the biomarkers,which is meaningful for the early diagnosis of the patient with high-risk for ARDS and provide evidence for the early treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The investigators studied patients at high risk of acute respiratory distress syndrome (ARDS) and ARDS patients. The patients with ARDS were the case group, and the patients without ARDS were the control group .Sample size estimate :set alpha =0.05,1- beta =0.8, estimated cases exposure rate was 50%, the control group estimated exposure rate was 35%, according to a case-control study of sample size estimation formula for sample size calculation, and considering the loss rate is 10%, the sample size for each group of 188 cases, two groups of 376 cases. The plasma, blood and bronchoalveolar lavage fluid will be collected during the diagnosis and treatment，to study biomarkers related to the onset of ARDS, such as protein markers,genetic polymorphisms and epigenetic markers.The observation data of two groups will be compared .The clinical data are collected at the given time point. The stepwise regression (forward-conditional) will be used for establishing a multivariate unconditional logistic regression model that will contribute to screened the main risk factor and protective factors that affect the ARDS. And these factor will help to established the early warning model and the risk function of ARDS in high-risk patients, which will contribute to predict the risk of ARDS in high-risk patients.All information about the subjects is strictly confidential, and the results of the study may be reported at medical conferences and published in scientific journals, but any individual who can identify subjects will not be able to use.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • Center of Respiratory and Critical Care Medicine，Department Of Gerontology and Secret Service Medicine, Xinqiao Hospital, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city

Description

Inclusion Criteria:

  1. High-risk cases ARDS inclusion criteria:

    • Acute onset (within 1 weeks)
    • Pneumonia,Aspiration,Sepsis,Acute pancreatitis,Shock,High-risk trauma and other unexpected severe diseases.
    • Pao2/Fio2>300mmhg
    • 18 to 80 years old
    • The subjects agreed to sign the informed consent

  2. ARDS Inclusion criteria:

    • Acute onset (within 1 weeks)
    • Pneumonia,Aspiration,Sepsis,Acute pancreatitis,Shock,High-risk trauma and other unexpected severe diseases.
    • Pao2/Fio2<300mmhg
    • 18 to 80 years old
    • The subjects agreed to sign the informed consent

Exclusion Criteria:

  • patients who developed ARDS before initial evaluation or blood collection
  • patients who were rehospitalized
  • the hospital stay was shorter than 7 days, and it was unfeasible to determine the clinical outcome
  • patients who died within 6h of admission
  • patients had a history of chronic interstitial lung disease
  • patients with an age of less than 18 years old
  • Patients were immunodeficiency (eg, eukaemia) or treated with cytotoxic drugs
  • patients who were pregnant
  • patients who were refused to join.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
case group
patients with ARDS
control group
patients Without ARDS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the change of protein biomarkers expression
Time Frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.
The protein biomarkers include surfactant protein(SP-D)，Clara Cell Protein 16(CC-16)，Angiopoietin-2(Ang-2)，von Willebrand factor(vWF)，Lipopolysaccharide-Binding Protein(LBP) and plasminogen activator inhibitor-1(PAI-1).The subjects will be observed for the content and expression changes of the items mentioned above at day0,1,2,3,4,7. Among participants, for case group patients ,the observation time point,day14 will be added.
Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.
the change of microRNA-126(miR-126) expression
Time Frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.
The subjects will be observed for the content and expression changes of the miR-126 at day0,1,2,3,4,7. Among participants, for case group patients ,the observation time point,day14 will be added.
Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.
the change of microRNA-146a(miR-146a) expression
Time Frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.
The subjects will be observed for the content and expression changes of the miR-146a at day0,1,2,3,4,7. Among participants, for case group patients ,the observation time point,day14 will be added.
Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.
Detection of methylation of occludin (OCLN) gene
Time Frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.
Detecting the OCLN gene methylation is based on microarray methylation pattern analysis.The subjects will be detected OCLN gene methylation at day0,1,2,3,4,7. Among participants, for case group patients ,the observation time point day14 will be added.
Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.
Analysis of gene polymorphism
Time Frame: Day 0
Detecting the genetic polymorphisms,it include mannose binding lectin-2 gene (The Single Nucleotide Polymorphism database (dbSNP) identification number (ID): rs1800450) and lipopolysaccharide-binding peptide (LBP) gene（The Single Nucleotide Polymorphism database (dbSNP) ID: rs2232618）
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mingdong Hu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMMUHMD76

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Distress Syndrome, Adult

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings