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

NCT02944279 | Completed

• 1 other identifier: 2009-1014
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Distress Syndrome, ARDS

Outcome Measures

Primary Outcomes (2)

• ARDS development-Berlin definition

  60 days

• ARDS survival

  60 days

Study Arms (5)

Peking University Third Hospital

Beijing Friendship Hospital

Beijing Shijitan Hospital

Beijing Xiyuan Hospital

China-Japan Friendship Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population is from five clinical and surgical ICUs in Beijing metropolitan area: Peking University Third Hospital in the northwest of Beijing, Beijing Friendship Hospital in the south, Beijing Shijitan Hospital in the middle, Beijing Xiyuan Hospital in the west, and China-Japan Friendship Hospital in the northeast.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Friendship Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Beijing Xiyuan Hospital: collaborator
• China-Japan Friendship Hospital: collaborator

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 25, 2016
• Study Start: January 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share