Clinical trial NCT02644798: Nucleotide Polymorphism in ARDS Outcome
Official title: Nucleotide Polymorphism in ARDS Outcome: a Whole Exome Sequencing Association Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Keywords: ARDS
Nucleotide polymorphism
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ARDS adult patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of survived participants
timeFrame: through study completion, an average of 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Southeast University
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Jingyuan Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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):331-338. doi: 10.1164/rccm.201603-0645OC.
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.
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. No abstract available.
citation: 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.
citation: 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.