NCT02944279

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

Completed Last updated 23 October 2016

What this trial tests

trial in Acute Respiratory Distress Syndrome, ARDS in 500 participants. Completed in 1 August 2014.

Timeline

1 January 2011

Primary endpoint
1 August 2014

1 August 2014

Quick facts

Lead sponsor	Peking University Third Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 January 2011
Primary completion	1 August 2014
Estimated completion	1 August 2014

Conditions studied

• Acute Respiratory Distress Syndrome, ARDS — all drugs for Acute Respiratory Distress Syndrome, ARDS →

Sponsor

Peking University Third Hospital

Who can join

18 and older, any sex, with Acute Respiratory Distress Syndrome, ARDS. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• ARDS development-Berlin definition
  Time frame: 60 days
• ARDS survival
  Time frame: 60 days

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Neutrophils to Treat Acute Respiratory Distress Syndrome in Coronavirus Disease.
   Chiang CC, Korinek M, Cheng WJ, Hwang TL. · · 2020 · cited 97× · PMID 33162887 · DOI 10.3389/fphar.2020.572009
2. Predictive model for acute respiratory distress syndrome events in ICU patients in China using machine learning algorithms: a secondary analysis of a cohort study.
   Ding XF, Li JB, Liang HY, Wang ZY, et al · · 2019 · cited 41× · PMID 31570096 · DOI 10.1186/s12967-019-2075-0
3. Neutrophil-Dependent Immunity During Pulmonary Infections and Inflammations.
   Effah CY, Drokow EK, Agboyibor C, Ding L, et al · · 2021 · cited 26× · PMID 34737734 · DOI 10.3389/fimmu.2021.689866