NCT02644798

Brief Summary

Acute respiratory distress syndrome (ARDS) is characterized by increased pulmonary vascular permeability and reduced aerated lung tissue. With an extremely high hospital mortality among 35 - 46%, current therapeutic strategies to increase ARDS survival are still limited. Advances in etiology and pathology of ARDS are urging. Numerous genetic variants were identified associated with ARDS outcome. By whole-exome sequencing association study, our goal was to explore the associations between genetic variants and ARDS outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

April 20, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

April 20, 2015

Last Update Submit

March 10, 2022

Conditions

ARDS

Keywords

ARDSNucleotide polymorphism

Outcome Measures

Primary Outcomes (1)

  • Number of survived participants

    Survivors and non-survivors in ICU

    through study completion, an average of 28 day

Study Arms (1)

ARDS patients

Adult ARDS (according to Berlin definition) patients were enrolled in the trial. The diagnostic criteria included (a) within one week of a known clinical insult or new or worsening respiratory symptoms; (b) chest imaging showing that bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules; (c) respiratory failure not fully explained by cardiac failure or fluid overload; and (d) arterial partial pressure of oxygen / fraction of inspiration oxygen (PaO2/FiO2 ratio, P/F ratio) less than or equal to 300 mmHg.

Other: Baseline-recorded data recorded

Interventions

Baseline-recorded data recordedOTHER

Baseline-recorded data recorded. Peripheral blood samples were drawn.

ARDS patients

Eligibility Criteria

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

ARDS adult patients

You may qualify if:

  • Adult ARDS (according to Berlin definition) patients were enrolled in the trial.
  • The diagnostic criteria included
  • within one week of a known clinical insult or new or worsening respiratory symptoms;
  • chest imaging showing that bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules;
  • respiratory failure not fully explained by cardiac failure or fluid overload;
  • arterial partial pressure of oxygen / fraction of inspiration oxygen (PaO2/FiO2 ratio, P/F ratio) less than or equal to 300 mmHg.

You may not qualify if:

  • Patients refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (5)

  • Famous KR, Delucchi K, Ware LB, Kangelaris KN, Liu KD, Thompson BT, Calfee CS; ARDS Network. Acute Respiratory Distress Syndrome Subphenotypes Respond Differently to Randomized Fluid Management Strategy. Am J Respir Crit Care Med. 2017 Feb 1;195(3):331-338. doi: 10.1164/rccm.201603-0645OC.

    PMID: 27513822RESULT

  • Calfee CS, Janz DR, Bernard GR, May AK, Kangelaris KN, Matthay MA, Ware LB. Distinct molecular phenotypes of direct vs indirect ARDS in single-center and multicenter studies. Chest. 2015 Jun;147(6):1539-1548. doi: 10.1378/chest.14-2454.

    PMID: 26033126RESULT

  • Shankar-Hari M, McAuley DF. Acute Respiratory Distress Syndrome Phenotypes and Identifying Treatable Traits. The Dawn of Personalized Medicine for ARDS. Am J Respir Crit Care Med. 2017 Feb 1;195(3):280-281. doi: 10.1164/rccm.201608-1729ED. No abstract available.

    PMID: 28145757RESULT

  • Calfee CS, Delucchi K, Parsons PE, Thompson BT, Ware LB, Matthay MA; NHLBI ARDS Network. Subphenotypes in acute respiratory distress syndrome: latent class analysis of data from two randomised controlled trials. Lancet Respir Med. 2014 Aug;2(8):611-20. doi: 10.1016/S2213-2600(14)70097-9. Epub 2014 May 19.

    PMID: 24853585RESULT

  • Xu JY, Liu AR, Wu ZS, Xie JF, Qu XX, Li CH, Meng SS, Liu SQ, Yang CS, Liu L, Huang YZ, Guo FM, Yang Y, Qiu HB. Nucleotide polymorphism in ARDS outcome: a whole exome sequencing association study. Ann Transl Med. 2021 May;9(9):780. doi: 10.21037/atm-20-5728.

    PMID: 34268393DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

Study Officials

  • Jingyuan Xu, M.D.

    Southeast University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2015

First Posted

January 1, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 30, 2017

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

CN(1)