Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • 1: patient at High risk for ARDSp
    • Severe pneumonia and(PaO2/FIO2)>300mmHg
  • 2: patient at High risk for ARDSexp
    • Severe sepsis and without ARDS
  • 3: mild ARDS
    • PaO2/FiO2=201~300 mmHg,and PEEP or CPAP≤5 cm
  • 4: moderate ARDS
    • PaO2/FIO2=101~200 mmHg,且PEEP≥5 cm H2O
  • 5: severe ARDS
    • PaO2/FIO2≤100 mmHg,且PEEP≥10 cm H2O

Clinical Trial Outcome Measures

Primary Measures

  • Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS
    • Time Frame: baseline
  • Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS
    • Time Frame: 1 month

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xiangya Hospital of Central South University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pinhua Pan, MD, Doctor, Principal Investigator, Xiangya Hospital of Central South University
  • Overall Contact(s)
    • Pinhua Pan, MD, Doctor, +86 13574810968, pinhuapan668@126.com

References

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.

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.

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.

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