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NCT02885675 Clinical Trial

An Observational Study of the Correlation Between miRNA in Peripheral Blood and Prognosis in Patients With ARDS

ARDS Clinical Trial

Official title:
An Observational Study of the Correlation Between miRNA in Peripheral Blood and Prognosis in Patients With ARDS

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02885675
Other study ID # ARDS miRNA
Secondary ID
Status Recruiting
Phase N/A
First received August 25, 2016
Last updated August 30, 2016
Start date March 2016
Est. completion date February 2017

Study information
Verified date August 2016
Source Southeast University, China
Contact Hunag Yingzi, doctor
Phone +8613951693278
Email yz_huang@126.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

To evaluate the correlation between the value of miRNA related to ARDS and vascular endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in patients with ARDS.

Description:

After consulting literature, we obtain 14 miRNAs related to ARDS and vascular endothelial cell(ARDS-VEC-miRNAs) and 2 biomarkers of scathing vascular endothelial.The ARDS-VEC-miRNAs include miR-15a-5p,miR-16-5p,miR-21-5p,miR-24-3p,miR-26a-5p,miR-27a-3p,miR-27b-3p,miR-126-3p,miR-150-5p,miR-146a-5p,miR-155-5p,miR-221-3p,miR-223-3p,miR-320a.The biomarkers of scathing vascular endothelial include vascular cell adhesion molecule-1(VCAM-1),von Willebrand factor(vWF).20 healthy controls and 60 patients diagnose as ARDS in ICU were included in this study.we blood every participants within 24 hours after enrollment and obtain the plasma.Then, we detecte ARDS-VEC-miRNAs,VCAM-1,vWF levels in plasma by real-time quantitative PCR,record the severity of the illness and survival status within 28 days of every patients.Finally,we evaluate the correlation between the value of miRNA related to ARDS and vascular endothelial cell and ARDS severity, vascular endothelial cell damaging degree，mortality in patients with ARDS.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:(1)Admitted to ICU, ARDS patients(Berlin criteria), (2)Patients diagnosed ARDS within 24 hours, (3)Patients age between 18 years old and 85 years.

Exclusion Criteria:1)Pregnant women, 2)Patients with malignant tumor, 3)Immunosuppression or immunocompromised patients.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• blood sampling
sample no more than 3ml

Locations
Country Name City State
China Zhong-Da hospital 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 mortality 28-day Yes
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