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

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. This project aims to detect novel biomarkers from peripheral blood , which 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. Different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS biomarker.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome

Detailed Description

Background 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. This project aims to detect novel biomarkers from peripheral blood , which 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. Different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS biomarker.

Eligibility Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples

Study Population Patients who have ARDS and admitted in hospital

Primary Outcome Measures:

ILC2 and ILC3 number from peripheral blood of ARDS patients

Secondary Outcome Measures:

APACHE III score [ Time Frame: baseline, 1week, 2 weeks ] PaO2/FiO2 ratio[ Time Frame: baseline, 1week, 2 weeks ] Mortality or multi-organ failure [ Time Frame: 1 month ]

Groups:

1. Mild ARDS PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm
2. Moderate ARDS PaO2/FIO2=101～200 mmHg，and PEEP≥5 cm H2O
3. Severe ARDSPaO2/FIO2≤100 mmHg，and PEEP≥10 cm H2O
4. Healthy

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Participation Criteria

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 who have ARDS and admitted in hospital

Description

Inclusion Criteria:

• Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples Study Population：Patients who have ARDS and admitted in hospital 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ARDS group
control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ILC 3	innate lymphoid cells 3	1 months after the onset
ILC 2	innate lymphoid cells 2	1 months after the onset

Secondary Outcome Measures

Outcome Measure	Time Frame
APACHE III score	1 months after the onset
PaO2/FiO2 ratio	1 months after the onset
Mortality or multi-organ failure	1 months after the onset

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Southern Medical University
• Investigators: Study Chair: Jinhong Wang, M.D., The Third Affiliated Hospital of Southern Medical University; Principal Investigator: Hui Peng, M.M., The Third Affiliated Hospital of Southern Medical University; Study Director: Hong Yang, M.D., The Third Affiliated Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Estimate): November 21, 2016
• Last Update Submitted That Met QC Criteria: November 18, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: ARDS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ARDS-ILC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No