Neutrophil Elastase and Elafin as Prognostic Biomarker for Acute Respiratory Distress Syndrome
NCT ID: NCT02944279
Last Updated: 2016-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2011-01-31
2014-08-31
Brief Summary
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ARDS is generally accompanied by the disruption in alveolar-capillary barrier permeability, which subsequently caused an influx of neutrophils into the interstitium and alveolar space. It was reported that the aggregation, adhesion activation and release proteases of neutrophils are the key pathogenesis of ARDS pulmonary edema. Neutrophil Elastase (HNE), the most crucial protease generated in neutrophil azurophilic granules, plays an important role in various inflammations, especially the lung injury. The destructive action of HNE on almost all extracellular matrix influences cell signaling through cleavage of surface receptors. Once released in circulation, HNE is rapidly inactivated by conjugation with PI3. This local inhibitor reduces HNE mediated tissue injury and inflammation. Thus, the investigators plan to conduct a cohort study with repeated measures to examine the diagnostic and prognostic value of HNE and PI3 for ARDS.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Peking University Third Hospital
No interventions assigned to this group
Beijing Friendship Hospital
No interventions assigned to this group
Beijing Shijitan Hospital
No interventions assigned to this group
Beijing Xiyuan Hospital
No interventions assigned to this group
China-Japan Friendship Hospital
No interventions assigned to this group
Eligibility Criteria
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Exclusion Criteria
* History of chronic lung diseases, such as interstitial pulmonary fibrosis or bronchiolitis
* history of pneumonectomy
* Treatment with immunomodulating therapy other than corticosteroids, such as granulocyte colony stimulating factor, cyclophosphamide, cyclosporine, interferon, or TNF-α antagonists
* Presence of other immunodeficient conditions, such as HIV infection, leukemia, or neutropenia (absolute neutrophil count \<1000/μl)
* History of organs or bone marrow transplant other than autologous bone marrow transplant
* Directive to withhold intubation
* ICU stay duration\<72h
* Patient developed ARDS before ICU admission. Sepsis and septic shock were defined according to the Berlin definition
18 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Beijing Shijitan Hospital, Capital Medical University
OTHER
Beijing Xiyuan Hospital
UNKNOWN
China-Japan Friendship Hospital
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Xi Zhu
Professor
Other Identifiers
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2009-1014
Identifier Type: -
Identifier Source: org_study_id