ALI/ARDS Clinical Sub-phenotyping Study

NCT06123962 | Recruiting

• 1 other identifier: 2022YFC2504401
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Construct a structured clinical data and biosample information platform for Chinese patients with acute lung injury/ acute respiratory distress syndrome.
2. 2.By deciphering the heterogeneity of patients with acute lung injury/ acute respiratory distress syndrome, achieve clinical, longitudinal physiological, and biological sub-phenotyping to guide individualized precision treatment and improve prognosis.

Conditions

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Keywords

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Sub-phenotypes; Treatment strategies

Outcome Measures

Primary Outcomes (2)

• ICU mortality

  In ICU mortality

  up to 12 weeks

• hospital mortality

  In hospital mortality

  up to 24 weeks

Secondary Outcomes (4)

• 28 days without mechanical ventilation

  up to 28 days

• length of stay in the ICU

  up to 12 weeks

• Total length of hospital stay

  up to 24 weeks

• Mortality at 1 year after discharge

  through study completion, an average of 1 year

Interventions

Collect peripheral blood and bronchoalveolar lavage fluid PROCEDURE

Peripheral venous blood will be collected and stored from the study participants at a total of five time points: Day 0, Day 1, Day 2, Day 3 after admission to the ICU, and the day of ICU discharge/death. The collection will be conducted after assessing the patients' eligibility for ARDS diagnosis. Each time point will involve the collection of one tube of peripheral venous blood, totaling 5 mL per sample. Within 24 hours after patients' admission to the ICU and meeting the assessment criteria for ARDS diagnosis, bronchoalveolar lavage fluid (BALF) will be collected and retained, totaling 10 mL.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Updated global diagnostic criteria for Acute Respiratory Distress Syndrome (ARDS) in 2023 are as follows: Supportive respiratory criteria: Endotracheal intubation, or non-invasive ventilation (NIV)/continuous positive airway pressure (CPAP) with minimum expiratory positive airway pressure (EPAP) ≥ 5 cmH2O, or high-flow nasal oxygen therapy with a minimum flow rate ≥ 30 L/min. Hypoxemia criteria: Arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) ≤ 300 mmHg, or peripheral oxygen saturation to fraction of inspired oxygen ratio (SpO2/FiO2) ≤ 315 mmHg, with simultaneous peripheral oxygen saturation (SpO2) ≤ 97%. Radiographic criteria: Chest X-ray, chest computed tomography (CT), or trained ultrasound confirming bilateral pulmonary opacities.

You may qualify if:

• Meet the diagnostic criteria for Acute Respiratory Distress Syndrome (ARDS) according to the updated global definition in 2023.
• The patient or their legal representative signs an informed consent form.

You may not qualify if:

• Individuals aged less than 18 years old.
• Those who refuse to participate in the study.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

Jingen Xia

Beijing, China

RECRUITING

Related Publications (5)

• Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available.

  PMID: 28792873 BACKGROUND

• Huang X, Zhang R, Fan G, Wu D, Lu H, Wang D, Deng W, Sun T, Xing L, Liu S, Wang S, Cai Y, Tian Y, Zhang Y, Xia J, Zhan Q; CHARDSnet group. Incidence and outcomes of acute respiratory distress syndrome in intensive care units of mainland China: a multicentre prospective longitudinal study. Crit Care. 2020 Aug 20;24(1):515. doi: 10.1186/s13054-020-03112-0.

  PMID: 32819400 BACKGROUND

• Reilly JP, Calfee CS, Christie JD. Acute Respiratory Distress Syndrome Phenotypes. Semin Respir Crit Care Med. 2019 Feb;40(1):19-30. doi: 10.1055/s-0039-1684049. Epub 2019 May 6.

  PMID: 31060085 BACKGROUND

• Shah FA, Meyer NJ, Angus DC, Awdish R, Azoulay E, Calfee CS, Clermont G, Gordon AC, Kwizera A, Leligdowicz A, Marshall JC, Mikacenic C, Sinha P, Venkatesh B, Wong HR, Zampieri FG, Yende S. A Research Agenda for Precision Medicine in Sepsis and Acute Respiratory Distress Syndrome: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2021 Oct 15;204(8):891-901. doi: 10.1164/rccm.202108-1908ST.

  PMID: 34652268 BACKGROUND

• 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: 24853585 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

We plan to collect peripheral blood and bronchoalveolar lavage fluid.

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Interventions

Bronchoalveolar Lavage Fluid

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Bronchoalveolar Lavage; Therapeutic Irrigation; Investigative Techniques

Study Officials

• Jingen Xia

  China-Japan Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Jingen Xia, M.D

CONTACT

+8613466396561; 13466396561@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: November 9, 2023
• Study Start: December 14, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)