Nucleotide Polymorphism in ARDS Outcome

Completed

• Conditions: ARDS
• Interventions: Other: Baseline-recorded data recorded

• Registration Number: NCT02644798
• Lead Sponsor: Southeast University, China

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.

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 Timeline

• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-12-31
• Study Start: 2016-01-01
• Study First Posted: 2016-01-01
• Primary Completion: 2016-12-01
• Study Completion: 2017-06-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARDS patients	Baseline-recorded data recorded	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.

Primary Outcome Measures

Name	Time	Method
Number of survived participants	through study completion, an average of 28 day	Survivors and non-survivors in ICU

Trial Locations

Locations (1)

Southeast University; 🇨🇳 Nanjing, Jiangsu, China