NCT02625064

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

November 24, 2015

Last Update Submit

December 5, 2015

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDSbiomarkersproteomic

Outcome Measures

Primary Outcomes (2)

  • Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS

    baseline

  • Analysis of serum proteins directly by proteomics analysis to identify new biomarkers of ARDS

    1 month

Secondary Outcomes (3)

  • APACHE III score

    baseline, 1week, 2 weeks

  • PaO2/FiO2 ratio

    baseline, day 3, day 5, 1week, 2 weeks

  • Mortality or multi-organ failure

    1 month

Study Arms (5)

1: patient at High risk for ARDSp

Severe pneumonia and（PaO2/FIO2）\>300mmHg

Other: Blood samples collection before treatmentOther: Blood samples collection after treatmentOther: laboratory biomarker proteomic analysis

2: patient at High risk for ARDSexp

Severe sepsis and without ARDS

Other: Blood samples collection before treatmentOther: Blood samples collection after treatmentOther: laboratory biomarker proteomic analysis

3: mild ARDS

PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm

Other: Blood samples collection before treatmentOther: Blood samples collection after treatmentOther: laboratory biomarker proteomic analysis

4: moderate ARDS

PaO2/FIO2=101～200 mmHg，且PEEP≥5 cm H2O

Other: Blood samples collection before treatmentOther: Blood samples collection after treatmentOther: laboratory biomarker proteomic analysis

5: severe ARDS

PaO2/FIO2≤100 mmHg，且PEEP≥10 cm H2O

Other: Blood samples collection before treatmentOther: Blood samples collection after treatmentOther: laboratory biomarker proteomic analysis

Interventions

Blood samples collection before treatmentOTHER
1: patient at High risk for ARDSp2: patient at High risk for ARDSexp3: mild ARDS4: moderate ARDS5: severe ARDS
Blood samples collection after treatmentOTHER
1: patient at High risk for ARDSp2: patient at High risk for ARDSexp3: mild ARDS4: moderate ARDS5: severe ARDS
laboratory biomarker proteomic analysisOTHER
1: patient at High risk for ARDSp2: patient at High risk for ARDSexp3: mild ARDS4: moderate ARDS5: severe ARDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • The Berlin definition of acute respiratory distress syndrome
  • ATS definition of severe pneumonia

You may not qualify if:

  • age below 18 years
  • pregnancy
  • Expected survival under 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, China

Location

Related Publications (3)

  • 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.

    PMID: 23934723BACKGROUND

  • 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. No abstract available.

    PMID: 26174184BACKGROUND

  • 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.

    PMID: 19858233BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Pinhua Pan, MD, Doctor

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pinhua Pan, MD, Doctor

CONTACT

+86 13574810968pinhuapan668@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 9, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

CN(1)