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Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome

NCT ID: NCT02625064

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Distress Syndrome

Keywords

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ARDS biomarkers proteomic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1: patient at High risk for ARDSp

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

Blood samples collection before treatment

Intervention Type OTHER

Blood samples collection after treatment

Intervention Type OTHER

laboratory biomarker proteomic analysis

Intervention Type OTHER

2: patient at High risk for ARDSexp

Severe sepsis and without ARDS

Blood samples collection before treatment

Intervention Type OTHER

Blood samples collection after treatment

Intervention Type OTHER

laboratory biomarker proteomic analysis

Intervention Type OTHER

3: mild ARDS

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

Blood samples collection before treatment

Intervention Type OTHER

Blood samples collection after treatment

Intervention Type OTHER

laboratory biomarker proteomic analysis

Intervention Type OTHER

4: moderate ARDS

PaO2/FIO2=101～200 mmHg，且PEEP≥5 cm H2O

Blood samples collection before treatment

Intervention Type OTHER

Blood samples collection after treatment

Intervention Type OTHER

laboratory biomarker proteomic analysis

Intervention Type OTHER

5: severe ARDS

PaO2/FIO2≤100 mmHg，且PEEP≥10 cm H2O

Blood samples collection before treatment

Intervention Type OTHER

Blood samples collection after treatment

Intervention Type OTHER

laboratory biomarker proteomic analysis

Intervention Type OTHER

Interventions

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Blood samples collection before treatment

Intervention Type OTHER

Blood samples collection after treatment

Intervention Type OTHER

laboratory biomarker proteomic analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pinhua Pan, MD, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

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Xiangya Hospital

Changsha, Hunan, China

Site Status

Countries

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China

Central Contacts

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Pinhua Pan, MD, Doctor

Role: CONTACT

Phone: +86 13574810968

Email: [email protected]

Facility Contacts

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Pinhua Pan, MD，Doctor

Role: primary

References

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Janz DR, Ware LB. Biomarkers of ALI/ARDS: pathogenesis, discovery, and relevance to clinical trials. Semin Respir Crit Care Med. 2013 Aug;34(4):537-48. doi: 10.1055/s-0033-1351124. Epub 2013 Aug 11.

Reference Type BACKGROUND
PMID: 23934723 (View on PubMed)

Ware LB, Calfee CS. Biomarkers of ARDS: what's new? Intensive Care Med. 2016 May;42(5):797-799. doi: 10.1007/s00134-015-3973-0. Epub 2015 Jul 15. No abstract available.

Reference Type BACKGROUND
PMID: 26174184 (View on PubMed)

Ware LB, Koyama T, Billheimer DD, Wu W, Bernard GR, Thompson BT, Brower RG, Standiford TJ, Martin TR, Matthay MA; NHLBI ARDS Clinical Trials Network. Prognostic and pathogenetic value of combining clinical and biochemical indices in patients with acute lung injury. Chest. 2010 Feb;137(2):288-96. doi: 10.1378/chest.09-1484. Epub 2009 Oct 26.

Reference Type BACKGROUND
PMID: 19858233 (View on PubMed)

Other Identifiers

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20151030

Identifier Type: -

Identifier Source: org_study_id