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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02967471

Enrollment

120

Registered

2016-11-18

Start date

2017-10-31

Completion date

2018-12-31

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
ILC 3	1 months after the onset	innate lymphoid cells 3
ILC 2	1 months after the onset	innate lymphoid cells 2

Secondary

Measure	Time frame
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

Contacts

Primary ContactJinhong Wang, M.D.

leechy911@126.com+86 13113319966

Backup ContactHui Peng, M.M.

penghui230@126.com020-62784382

Outcome results