Discovery of New Early Detection Biomarkers of Acute Respiratory Distress Syndrome (ARDS)

December 5, 2015 updated by: Xiangya Hospital of Central South University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients at High risk for Extra-pulmonary ARDS and pulmonary ARDS; patients who have ARDS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Pinhua Pan, MD, Doctor, Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

December 5, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 5, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20151030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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