Clinical trial NCT02967471: Discovery of New Early Detection Biomarkers From Peripheral Blood of Acute Respiratory Distress Syndrome(ARDS)
Official title: Discovery of New Early Detection Biomarkers From Peripheral Blood of Acute Respiratory Distress Syndrome(ARDS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Lead sponsor: The Third Affiliated Hospital of Southern Medical University
Sponsor class: OTHER_GOV
First posted: 2016-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have ARDS and admitted in hospital

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

Eligibility criteria: 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

Primary outcomes:
measure: ILC 3
timeFrame: 1 months after the onset
measure: ILC 2
timeFrame: 1 months after the onset
Secondary outcomes:
measure: APACHE III score
timeFrame: 1 months after the onset
measure: PaO2/FiO2 ratio
timeFrame: 1 months after the onset
measure: Mortality or multi-organ failure
timeFrame: 1 months after the onset
Other outcomes:
Locations:
Study officials:
affiliation: The Third Affiliated Hospital of Southern Medical University
name: Jinhong Wang, M.D.
role: STUDY_CHAIR
affiliation: The Third Affiliated Hospital of Southern Medical University
name: Hui Peng, M.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Southern Medical University
name: Hong Yang, M.D.
role: STUDY_DIRECTOR
References: