Glycocalyx Biomarkers in ARDS for Clinical Prognosis and Pulmonary Fibrosis

Endothelial Dysfunction Clinical Trial

Official title:

Predictive Value of Glycocalyx Biomarkers in Mechanical Ventilation of Patients With ARDS for Clinical Prognosis and Long-term Pulmonary Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03854565
• Other study ID #: Decorin-ARDS fibrosis study
• Status: Not yet recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• ARDS, Human
• Endothelial Dysfunction
• Fibrosis
• Mechanical Ventilation Pressure High
• Pulmonary Fibrosis
• Respiratory Distress Syndrome, Adult

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