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Status unknownNCT02967471Updated Nov 21, 2016

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

An observational study in Acute Respiratory Distress Syndrome, sponsored by The Third Affiliated Hospital of Southern Medical University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-21.

Sponsored by The Third Affiliated Hospital of Southern Medical University · Observational

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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
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Conditions studied

03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

The Third Affiliated Hospital of Southern Medical University is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients who have ARDS and admitted in hospital

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

Exclusion Criteria:

  • age below 18 years,pregnancy,Expected survival under 24 hours
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • ARDS group
  • control group
06

What researchers measure

Primary outcomes

  1. ILC 3

    innate lymphoid cells 3

    Time frame: 1 months after the onset

  2. ILC 2

    innate lymphoid cells 2

    Time frame: 1 months after the onset

Secondary outcomes

  1. APACHE III score

    Time frame: 1 months after the onset

  2. PaO2/FiO2 ratio

    Time frame: 1 months after the onset

  3. Mortality or multi-organ failure

    Time frame: 1 months after the onset

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02967471
Lead sponsor
The Third Affiliated Hospital of Southern Medical University
Responsible party
Hui Peng (Principal Investigator, The Third Affiliated Hospital of Southern Medical University) — Principal investigator
First posted
Nov 18, 2016
Start date
Oct 2017
Primary completion
Oct 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Nov 21, 2016

Study contacts

Jinhong Wang, M.D.
Contact
leechy911@126.com
+86 13113319966
Hui Peng, M.M.
Contact
penghui230@126.com
020-62784382
Jinhong Wang, M.D.
study chair · The Third Affiliated Hospital of Southern Medical University
Hui Peng, M.M.
principal investigator · The Third Affiliated Hospital of Southern Medical University
Hong Yang, M.D.
study director · The Third Affiliated Hospital of Southern Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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