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Trial record 8 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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

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ClinicalTrials.gov Identifier: NCT03236272
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Mingdong Hu, Third Military Medical University

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.

Condition or disease
Respiratory Distress Syndrome, Adult

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.

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Study Type : Observational
Estimated Enrollment : 376 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Group/Cohort
case group
patients with ARDS
control group
patients Without ARDS



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)


Biospecimen Retention:   Samples With DNA
whole blood ,plasma,bronchoalveolar lavage fluid


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects were selected from the Department of respiration, Xinqiao Hospital of Chongqing city
Criteria

Inclusion Criteria:

  1. High-risk cases ARDS inclusion criteria:

    • Acute onset (within 1 weeks)
    • Severe infection, severe trauma, severe acute pancreatitis.
    • 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)
    • Severe infection, severe trauma, severe acute pancreatitis
    • Pao2/Fio2<300mmhg
    • 18 to 80 years old
    • The subjects agreed to sign the informed consent

Exclusion Criteria:

  • Pulmonary embolism
  • Severe arrhythmia or acute myocardial ischemia
  • After cardiopulmonary resuscitation
  • Clinical diagnosis of chronic cardiac insufficiency
  • Chronic liver or renal insufficiency
  • Clinical diagnosis of malignant tumor
  • The subjects with chronic obstructive pulmonary disease (ESRD)
  • Chronic interstitial lung disease
  • Pregnancy
  • The subjects refused to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236272


Contacts
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Contact: Hu Mingdong, MD 13500362524 huhanshandd@163.com
Contact: Wang dan 18581290211 wada211@163.com

Locations
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China
Emergency Department, Xinqiao Hospital, Third Military Medical University Recruiting
Chongqing, China
Contact: HU MINGDONG, MD         
Sponsors and Collaborators
Mingdong Hu

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Responsible Party: Mingdong Hu, associate chief physician, Third Military Medical University
ClinicalTrials.gov Identifier: NCT03236272     History of Changes
Other Study ID Numbers: TMMUHMD76
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mingdong Hu, Third Military Medical University:
Biomarkers
High-Throughput Screening Assays
Respiratory Distress Syndrome, Adult
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury