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

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT02967471
• Lead Sponsor: The Third Affiliated Hospital of Southern Medical University

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.

Detailed Description

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

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-18
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21
• Study Start: 2017-10
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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 Criteria：Inclusion Criteria:The Berlin definition of acute respiratory distress syndrome,ATS definition of severe pneumonia

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ILC 2	1 months after the onset	innate lymphoid cells 2
ILC 3	1 months after the onset	innate lymphoid cells 3

Secondary Outcome Measures

Name	Time	Method
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