Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
1 other identifier
observational
376
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 1, 2017
CompletedStudy Start
First participant enrolled
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 25, 2020
March 1, 2020
3.3 years
July 24, 2017
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
the change of protein biomarkers expression
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
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
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
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
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
Study Arms (2)
case group
patients with ARDS
control group
patients Without ARDS
Eligibility Criteria
The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city
You may qualify if:
- Acute onset (within 1 weeks)
- Pneumonia,Aspiration,Sepsis,Acute pancreatitis,Shock,High-risk trauma and other unexpected severe diseases.
- Pao2/Fio2\>300mmhg
- to 80 years old
- The subjects agreed to sign the informed consent
- Acute onset (within 1 weeks)
- Pneumonia,Aspiration,Sepsis,Acute pancreatitis,Shock,High-risk trauma and other unexpected severe diseases.
- Pao2/Fio2\<300mmhg
- to 80 years old
- The subjects agreed to sign the informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mingdong Hulead
Study Sites (1)
Center of Respiratory and Critical Care Medicine，Department Of Gerontology and Secret Service Medicine, Xinqiao Hospital, Third Military Medical University
Chongqing, China
Biospecimen
whole blood ,plasma,bronchoalveolar lavage fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- associate chief physician
Study Record Dates
First Submitted
July 24, 2017
First Posted
August 1, 2017
Study Start
September 15, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03