Nucleotide Polymorphism in ARDS Outcome

ARDS Clinical Trial

Official title:

Nucleotide Polymorphism in ARDS Outcome: a Whole Exome Sequencing Association Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644798
• Other study ID #: 2015ZDSYLL014.0
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2022
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 30, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS

Intervention

Other:
• Baseline-recorded data recorded
Baseline-recorded data recorded. Peripheral blood samples were drawn.

Locations

Country	Name	City	State
China	Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

References & Publications (4)

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. do — View Citation

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. — View Citation

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):331-33 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of survived participants	Survivors and non-survivors in ICU	through study completion, an average of 28 day