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Status unknownNCT03296761Updated Nov 1, 2017

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

An observational study in Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS, sponsored by Jingyuan,Xu. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by Jingyuan,Xu · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Population admitted to ICU of Zhongda hospital ,diagnosed of ARDS

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

Exclusion Criteria:

  1. Pregnant women,
  2. Patients with malignant tumor,
  3. Immunosuppression or immunocompromised patients.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • ESM-1<5ng/ml
  • ESM-1≥5ng/ml
05

What researchers measure

Primary outcomes

  1. mortality

    Time frame: 28-day

06

Study locations

1 of 1 sites recruiting
  • Nanjing Zhongda Hospital, School of Medicine, Southeast University
    Nanjing, Jiangsu 210009, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03296761
Lead sponsor
Jingyuan,Xu
Responsible party
Jingyuan,Xu (chief doctor, Southeast University, China) — Sponsor-investigator
First posted
Sep 28, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Dec 20, 2017 (estimated)
Completion
Feb 20, 2018 (estimated)
Last update
Nov 1, 2017

Study contacts

Yuanyuan YU
Contact
220153911@seu.edu.cn
15651680953
Haibo qiu
Contact
haiboq2000@163.com
+862583262550
Haibo qiu
study chair · Zhong-Da Hospital, School of Medicine, Southeast University,

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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