Respiratory Distress Syndrome, AdultNCT03236272
Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
An observational study of Respiratory Distress Syndrome, Adult, run by Mingdong Hu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients were immunodeficiency (eg, eukaemia) or treated with cytotoxic drugs
- patients who were pregnant
- patients who were refused to join.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center of Respiratory and Critical Care Medicine，Department Of Gerontology and Secret Service Medicine, Xinqiao Hospital, Third Military Medical University
Chongqing
HU MINGDONG, MD
About this study
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Biomarkers, High-Throughput Screening Assays, Respiratory Distress Syndrome, Adult
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | patients with ARDS | |
| control group | patients Without ARDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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）
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start15 Sep 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingdong Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingdong Hu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236272
- Sponsor's protocol ID
- TMMUHMD76
- Status last verified
- Mar 2020
- First submitted
- 24 Jul 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT03236272
- Acronym / sponsor ID
- TMMUHMD76
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Biomarkers, High-Throughput Screening Assays, Respiratory Distress Syndrome, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Mingdong HuUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | –patients with ARDS |
| control group | – | –patients Without ARDS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city
Key inclusion criteria (12 listed)
- High-risk cases ARDS inclusion criteria:
- ARDS Inclusion criteria:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult, run by Mingdong Hu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Mingdong, MD (13500362524, huhanshandd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.