Clinical trial NCT02625064: Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome
Official title: Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
biomarkers
proteomic
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients at High risk for Extra-pulmonary ARDS and pulmonary ARDS; patients who have ARDS

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.

Eligibility 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

Primary outcomes:
measure: Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS
timeFrame: baseline
measure: Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS
timeFrame: 1 month
Secondary outcomes:
measure: APACHE III score
timeFrame: baseline, 1week, 2 weeks
measure: PaO2/FiO2 ratio
timeFrame: baseline, day 3, day 5, 1week, 2 weeks
measure: Mortality or multi-organ failure
timeFrame: 1 month
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Pinhua Pan, MD, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.