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

Central South University

Status: Unknown

Conditions: Acute Respiratory Distress Syndrome

Treatments: Other: laboratory biomarker proteomic analysis; Other: Blood samples collection after treatment; Other: Blood samples collection before treatment

Study type: Observational

Funder types: Other

Identifiers

NCT02625064

20151030

Details and patient eligibility

About

The goal of this project is to find a series novel biomarkers by differential proteomic techniques that can improve the early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate.

Full description

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. The goal of this project is to find a series novel biomarkers by differential proteomic techniques that 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. Studying blood specimens from different period ARDS patients by proteomic analysis. It can provide information on a complex composition of proteins that are differentially expressed, which could be used for discovering high sensitivity and specificity ARDS biomarker.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 5 patient groups

1: patient at High risk for ARDSp

Description:

Severe pneumonia and（PaO2/FIO2）\>300mmHg

Treatment:

Other: laboratory biomarker proteomic analysis

Other: Blood samples collection after treatment

Other: Blood samples collection before treatment

2: patient at High risk for ARDSexp

Description:

Severe sepsis and without ARDS

Treatment:

Other: laboratory biomarker proteomic analysis

Other: Blood samples collection after treatment

Other: Blood samples collection before treatment

3: mild ARDS

Description:

PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm

Treatment:

Other: laboratory biomarker proteomic analysis

Other: Blood samples collection after treatment

Other: Blood samples collection before treatment

4: moderate ARDS

Description:

PaO2/FIO2=101～200 mmHg，且PEEP≥5 cm H2O

Treatment:

Other: laboratory biomarker proteomic analysis

Other: Blood samples collection after treatment

Other: Blood samples collection before treatment

5: severe ARDS

Description:

PaO2/FIO2≤100 mmHg，且PEEP≥10 cm H2O

Treatment:

Other: laboratory biomarker proteomic analysis

Other: Blood samples collection after treatment

Other: Blood samples collection before treatment