Glycocalyx Biomarkers in ARDS for Clinical Prognosis and Pulmonary Fibrosis

February 22, 2019 updated by: Chun Pan, Southeast University, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

336

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital, Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients have been diagnosed ARDS with mechanical ventilation, and do not been used heparin, molecular heparin, chondroitin sulfuric acid.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild ARDS
patients have mild ARDS according to Berlin definition
Diagnostic test: Glycocalyx measurement，respiratory mechanics measurement
ELASA measure glycocalyx, measure plateau pressure, driving pressure
Moderate ARDS
patients have moderate ARDS according to Berlin definition
Diagnostic test: Glycocalyx measurement，respiratory mechanics measurement
ELASA measure glycocalyx, measure plateau pressure, driving pressure
Severe ARDS
patients have severe ARDS according to Berlin definition
Diagnostic test: Glycocalyx measurement，respiratory mechanics measurement
ELASA measure glycocalyx, measure plateau pressure, driving pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 days mortality from patients involved in the study
Time Frame: 28 days
28 days mortality from patients involved in the study
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT and syndecan-1 to evaluate pulmonary fibrosis
Time Frame: 1mon, 3mon and 6 month
pulmonary fibrosis evaluated by biomarker and CT
1mon, 3mon and 6 month
pulmonary function test to evaluate pulmonary function
Time Frame: 1mon, 3mon and 6 month
pulmonary function evaluated by pulmonary function test
1mon, 3mon and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Principal Investigator: Chun C Pan, Dr, Zhongda hospital, Southeast University, Jiangsu, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

February 17, 2019

First Submitted That Met QC Criteria

February 22, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Decorin-ARDS fibrosis study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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