Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Bio... | NCT03296761

Studies
Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury

NCT03296761

Sponsor

Jingyuan,Xu

Status

Unknown status

Last Update Posted

Nov 1, 2017Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Estimated

Primary Completion Date

Dec 20, 2017Estimated

Completion Date

Feb 20, 2018Estimated

First Submitted Date

Sep 25, 2017

First Submission Date that Met QC Criteria

Sep 27, 2017

First Posted Date

Sep 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2017

Last Update Posted Date

Nov 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its clinical significance.

Detailed Description

70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from these patients in the first day, the third day and the seventh day, detect ESM-1 level in plasma by ELISA. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the prognosis of the patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Measure	Description	Time Frame
mortality		28-day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to ICU diagnosed of ARDS (Berlin definition）in 48h
Patients age between 18 years old and 80 years.

Exclusion Criteria：

Pregnant women,
Patients with malignant tumor,
Immunosuppression or immunocompromised patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuanyuan YU	Contact	15651680953		220153911@seu.edu.cn
Haibo qiu	Contact	+862583262550		haiboq2000@163.com

Overall Officials

Name	Affiliation	Role
Haibo qiu	Zhong-Da Hospital, School of Medicine, Southeast University,	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Zhongda Hospital, School of Medicine, Southeast University	Recruiting	Nanjing	Jiangsu	210009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
ESM-1<5ng/ml
ESM-1≥5ng/ml