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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02967471
• Other study ID #: ARDS-ILC001
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 18, 2016
• Start date: October 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: The Third Affiliated Hospital of Southern Medical University
• Contact: Jinhong Wang, M.D.
• Phone: +86 13113319966
• Email: leechy911[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ILC 3	innate lymphoid cells 3	1 months after the onset	Yes
Primary	ILC 2	innate lymphoid cells 2	1 months after the onset	Yes
Secondary	APACHE III score		1 months after the onset	Yes
Secondary	PaO2/FiO2 ratio		1 months after the onset	Yes
Secondary	Mortality or multi-organ failure		1 months after the onset	Yes