Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

— ARDS  

Official title:

Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02625064
• Other study ID #: 20151030
• Status: Not yet recruiting
• Phase: N/A
• First received: November 24, 2015
• Last updated: December 5, 2015
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: December 2015
• Source: Xiangya Hospital of Central South University
• Contact: Pinhua Pan, MD, Doctor
• Phone: +86 13574810968
• Email: pinhuapan668[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• Blood samples collection before treatment

• Blood samples collection after treatment

• laboratory biomarker proteomic analysis

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View Citation

Ware LB, Calfee CS. Biomarkers of ARDS: what's new? Intensive Care Med. 2015 Jul 15. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS		baseline	No
Primary	Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS		1 month	No
Secondary	APACHE III score		baseline, 1week, 2 weeks	No
Secondary	PaO2/FiO2 ratio		baseline, day 3, day 5, 1week, 2 weeks	No
Secondary	Mortality or multi-organ failure		1 month	No