Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: Blood samples collection before treatment; Other: Blood samples collection after treatment; Other: laboratory biomarker proteomic analysis

• Registration Number: NCT02625064
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-24
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-05
• Last Update Submitted: 2015-12-05
• Study First Posted: 2015-12-09
• Last Update Posted: 2015-12-09
• Study Start: 2016-01
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Arm && Interventions

Group	Intervention	Description
1: patient at High risk for ARDSp	Blood samples collection after treatment	Severe pneumonia and（PaO2/FIO2）\>300mmHg
2: patient at High risk for ARDSexp	Blood samples collection before treatment	Severe sepsis and without ARDS
1: patient at High risk for ARDSp	laboratory biomarker proteomic analysis	Severe pneumonia and（PaO2/FIO2）\>300mmHg
3: mild ARDS	laboratory biomarker proteomic analysis	PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm
4: moderate ARDS	Blood samples collection before treatment	PaO2/FIO2=101～200 mmHg，且PEEP≥5 cm H2O
4: moderate ARDS	Blood samples collection after treatment	PaO2/FIO2=101～200 mmHg，且PEEP≥5 cm H2O
1: patient at High risk for ARDSp	Blood samples collection before treatment	Severe pneumonia and（PaO2/FIO2）\>300mmHg
3: mild ARDS	Blood samples collection after treatment	PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm
5: severe ARDS	Blood samples collection before treatment	PaO2/FIO2≤100 mmHg，且PEEP≥10 cm H2O
2: patient at High risk for ARDSexp	Blood samples collection after treatment	Severe sepsis and without ARDS
2: patient at High risk for ARDSexp	laboratory biomarker proteomic analysis	Severe sepsis and without ARDS
3: mild ARDS	Blood samples collection before treatment	PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm
4: moderate ARDS	laboratory biomarker proteomic analysis	PaO2/FIO2=101～200 mmHg，且PEEP≥5 cm H2O
5: severe ARDS	Blood samples collection after treatment	PaO2/FIO2≤100 mmHg，且PEEP≥10 cm H2O
5: severe ARDS	laboratory biomarker proteomic analysis	PaO2/FIO2≤100 mmHg，且PEEP≥10 cm H2O

Primary Outcome Measures

Name	Time	Method
Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS	1 month

Secondary Outcome Measures

Name	Time	Method
APACHE III score	baseline, 1week, 2 weeks
PaO2/FiO2 ratio	baseline, day 3, day 5, 1week, 2 weeks
Mortality or multi-organ failure	1 month

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, Hunan, China