The Evaluation of NETs, Caspase-1 and Cytokines in ARDS Patients

ARDS Clinical Trial

Official title:

IRF-1 Regulate Alveolar Macrophage Pyroptosis in Acute Lung Injury and of Which Will be Possible Mechanism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227107
• Other study ID #: 81470266
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2017
• Last updated: July 21, 2017
• Start date: January 1, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2017
• Source: Xiangya Hospital of Central South University
• Contact: Li Haitao, Doctor
• Phone: (+86)18684916132
• Email: 168101013[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. enrollment criteria and clinical data collection: follow the principles of medical ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS patients, in the active treatment at the same time, according to the Berlin standard severity of the disease divided into mild group, moderate Group and severe group, according to the prognosis during hospitalization is divided into survival group and death group. BALF specimens were collected on the day of admission to detect the levels of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen, fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis, oxygenation index; record the patient's mechanical ventilation time and other data;

2. Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage coke death level was a positive correlation between the Spearman rank correlation analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ, Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and ARDS severity was positively correlated;

3. To analyze the prognostic factors of different prognostic factors, to evaluate the content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term survival outcome prognostic value.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ARDS patients diagnosis within 3 days

• Over 18 years old but no more than 75 years old

Exclusion Criteria:

• Severe thoracic open trauma

• Pulmonary embolism

• Severe cardiovascular and cerebrovascular disease

• Endocrine system diseases

• Coagulation dysfunction

• Liver and kidney failure

• Malignant tumors

• Cardiogenic pulmonary edema

Related Conditions & MeSH terms

• ARDS

Locations

Country	Name	City	State
China	Xiangya hospital of Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neutrophil extracellular traps, caspase-1,cytokines measurement	Assessments with neutrophil extracellular traps be presented in ng/ml; Assessments with caspase-1 and cytokines be presented in pg/ml	4 years