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Neutrophil Elastase and Elafin as Prognostic Biomarker for Acute Respiratory Distress Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02944279
Enrollment
500
Registered
2016-10-25
Start date
2011-01-31
Completion date
2014-08-31
Last updated
2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, ARDS

Brief summary

The acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care unit (ICU) throughout the world. In recent years, much effort has been focused on the biological markers for their potential values to diagnose ARDS and outcomes. 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.

Interventions

None listed

Sponsors

Beijing Friendship Hospital
CollaboratorOTHER
Beijing Shijitan Hospital, Capital Medical University
CollaboratorOTHER
Beijing Xiyuan Hospital
CollaboratorUNKNOWN
China-Japan Friendship Hospital
CollaboratorOTHER
Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Exclusion criteria

* Age \<18 years * 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

Design outcomes

Primary

MeasureTime frame
ARDS development-Berlin definition60 days
ARDS survival60 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026