NCT02967471

Brief Summary

Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS. This project aims to detect novel biomarkers from peripheral blood , which can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate. Clinical data and blood sample were recorded before treatment and after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at enrolment. Different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS biomarker.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

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

November 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 16, 2016

Last Update Submit

November 18, 2016

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS

Outcome Measures

Primary Outcomes (2)

  • ILC 3

    innate lymphoid cells 3

    1 months after the onset

  • ILC 2

    innate lymphoid cells 2

    1 months after the onset

Secondary Outcomes (3)

  • APACHE III score

    1 months after the onset

  • PaO2/FiO2 ratio

    1 months after the onset

  • Mortality or multi-organ failure

    1 months after the onset

Study Arms (2)

ARDS group

control group

Eligibility Criteria

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

Patients who have ARDS and admitted in hospital

You may not qualify if:

  • age below 18 years,pregnancy,Expected survival under 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jinhong Wang, M.D.

    The Third Affiliated Hospital of Southern Medical University

    STUDY CHAIR

  • Hui Peng, M.M.

    The Third Affiliated Hospital of Southern Medical University

    PRINCIPAL INVESTIGATOR

  • Hong Yang, M.D.

    The Third Affiliated Hospital of Southern Medical University

    STUDY DIRECTOR

Central Study Contacts

Jinhong Wang, M.D.

CONTACT

+86 13113319966leechy911@126.com

Hui Peng, M.M.

CONTACT

020-62784382penghui230@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 18, 2016

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

November 21, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share