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

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

Study Overview

• Status: Unknown
• Conditions: Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS

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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Yuanyuan YU; Phone Number: 15651680953; Email: 220153911@seu.edu.cn
• Study Contact Backup: Name: Haibo qiu; Phone Number: +862583262550; Email: haiboq2000@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Nanjing Zhongda Hospital, School of Medicine, Southeast University
      • Contact: Yuanyuan YU; Phone Number: 15651680953; Email: 220153911@seu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS

Description

Inclusion Criteria:

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

Exclusion Criteria：

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ESM-1<5ng/ml
ESM-1≥5ng/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality	28-day

Collaborators and Investigators

• Sponsor: Jingyuan,Xu
• Investigators: Study Chair: Haibo qiu, Zhong-Da Hospital, School of Medicine, Southeast University,

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): December 20, 2017
• Study Completion (Anticipated): February 20, 2018

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2017ZDSYLL081-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No