NCT03296761

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
Last Updated

November 1, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

September 25, 2017

Last Update Submit

October 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • mortality

    28-day

Study Arms (2)

ESM-1<5ng/ml

ESM-1≥5ng/ml

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population admitted to ICU of Zhongda hospital ,diagnosed of ARDS

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Study Officials

  • Haibo qiu

    Zhong-Da Hospital, School of Medicine, Southeast University,

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief doctor

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 28, 2017

Study Start

November 1, 2017

Primary Completion

December 20, 2017

Study Completion

February 20, 2018

Last Updated

November 1, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations