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

Sponsor

Southeast University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT02885675

Collaborator

(none)

Enrollment

Location

11.1

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
ARDS	Other: blood sampling

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2017

Anticipated Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
ARDS	Other: blood sampling sample no more than 3ml
Healthy control	Other: blood sampling sample no more than 3ml

Arm

Intervention/Treatment

ARDS

Other: blood sampling

sample no more than 3ml

Healthy control

Other: blood sampling

sample no more than 3ml

Outcome Measures

Primary Outcome Measures

mortality [28-day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhong-Da hospital	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

Southeast University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jianfeng Xie, Zhongda Hospital, Southeast University, China

ClinicalTrials.gov Identifier:

NCT02885675

Other Study ID Numbers:

ARDS miRNA

First Posted:

Aug 31, 2016

Last Update Posted:

Aug 31, 2016

Last Verified:

Aug 1, 2016

Study Results

No Results Posted as of Aug 31, 2016