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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03854565
Other study ID # Decorin-ARDS fibrosis study
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date December 31, 2019

Study information

Verified date February 2019
Source Southeast University, China
Contact Chun C Pan, Dr
Phone +862583262550
Email panchun1982@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

ARDS is a severe disease in ICU, and could induce high mortality. Glycocalyx is an important matrix construction which covers endothelial cells, it could protect endothelial cells injury and the glycocalyx biomarkers could predict pulmonary injury.

Decorin is a member of the small leucine-rich proteoglycan (SLRP) family, contains a single glycosaminoglycan (GAG) chain and a core protein with 12 leucine-rich repeats. In the previous study, decorin is associated with cardiac and liver fibrosis, however, the effects of decorin on ARDS pulmonary fibrosis have not been clarified.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 336
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Age > 18yrs and <80yrs

2. Meet ARDS Berlin definition

3. With mechanical ventilation

Exclusion Criteria:

1. have chronic pulmonary disease

2. have use heparin or low molecular heparin or chondroitin sulfuric acid

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Glycocalyx measurement,respiratory mechanics measurement
ELASA measure glycocalyx, measure plateau pressure, driving pressure

Locations

Country Name City State
China Zhongda Hospital, Southeast University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 28 days mortality from patients involved in the study 28 days mortality from patients involved in the study 28 days
Secondary CT and syndecan-1 to evaluate pulmonary fibrosis pulmonary fibrosis evaluated by biomarker and CT 1mon, 3mon and 6 month
Secondary pulmonary function test to evaluate pulmonary function pulmonary function evaluated by pulmonary function test 1mon, 3mon and 6 month
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