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Discovery of New Early Detection Biomarkers From Peripheral Blood of Acute Respiratory Distress Syndrome(ARDS)

NCT ID: NCT02967471

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Background 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.

Eligibility Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples

Study Population Patients who have ARDS and admitted in hospital

Primary Outcome Measures:

ILC2 and ILC3 number from peripheral blood of ARDS patients

Secondary Outcome Measures:

APACHE III score \[ Time Frame: baseline, 1week, 2 weeks \] PaO2/FiO2 ratio\[ Time Frame: baseline, 1week, 2 weeks \] Mortality or multi-organ failure \[ Time Frame: 1 month \]

Groups:

1. Mild ARDS PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm
2. Moderate ARDS PaO2/FIO2=101～200 mmHg，and PEEP≥5 cm H2O
3. Severe ARDSPaO2/FIO2≤100 mmHg，and PEEP≥10 cm H2O
4. Healthy

Conditions

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Acute Respiratory Distress Syndrome

Keywords

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ARDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ARDS group

No interventions assigned to this group

control group

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* age below 18 years,pregnancy,Expected survival under 24 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Third Affiliated Hospital of Southern Medical University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hui Peng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinhong Wang, M.D.

Role: STUDY_CHAIR

The Third Affiliated Hospital of Southern Medical University

Hui Peng, M.M.

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated Hospital of Southern Medical University

Hong Yang, M.D.

Role: STUDY_DIRECTOR

The Third Affiliated Hospital of Southern Medical University

Central Contacts

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Jinhong Wang, M.D.

Role: CONTACT

Phone: +86 13113319966

Email: [email protected]

Hui Peng, M.M.

Role: CONTACT

Phone: 020-62784382

Email: [email protected]

Other Identifiers

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ARDS-ILC001

Identifier Type: -

Identifier Source: org_study_id