Nucleotide Polymorphism in ARDS Outcome

• Sponsor: Southeast University, China (Other)
• Overall Status: Completed
• CT.gov ID: NCT02644798
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS	Other: Baseline-recorded data recorded

Detailed Description

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. Then a few genetic risk factors have been discovered by large-scale genotyping approaches, from in vivo or in vitro models of lung injury, which highlight the importance of identifying genetic biomarkers of ARDS outcome to further improve stratification. The mutational landscape and variability at single nucleotide polymorphisms (SNP) with ARDS outcome in Chinese is unknown, not to mention their associations. By whole-exome sequencing association study, our goal was to explore the associations between genetic variants and ARDS outcome.

Study Design

• Study Type: Observational
• Actual Enrollment: 105 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Nucleotide Polymorphism in ARDS Outcome: a Whole Exome Sequencing Association Study
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. Number of survived participants [through study completion, an average of 28 day]

   Survivors and non-survivors in ICU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Adult ARDS (according to Berlin definition) patients were enrolled in the trial.

The diagnostic criteria included

1. within one week of a known clinical insult or new or worsening respiratory symptoms;

2. chest imaging showing that bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules;

3. respiratory failure not fully explained by cardiac failure or fluid overload;

4. arterial partial pressure of oxygen / fraction of inspiration oxygen (PaO2/FiO2 ratio, P/F ratio) less than or equal to 300 mmHg.

Exclusion criteria:

Patients refused to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southeast University	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

• Southeast University, China

Investigators

• Principal Investigator: Jingyuan Xu, M.D., Southeast University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jingyuan,Xu, Principal Investigator, Southeast University, China
• ClinicalTrials.gov Identifier: NCT02644798
• Other Study ID Numbers: 2015ZDSYLL014.0
• First Posted: Jan 1, 2016
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jingyuan,Xu, Principal Investigator, Southeast University, China: ARDS; Nucleotide polymorphism

Study Results

No Results Posted as of Mar 15, 2022