ALI/ARDS Clinical Sub-phenotyping Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital
About this trial
1. Construct a structured clinical data and biosample information platform for Chinese patients with acute lung injury/ acute respiratory distress syndrome. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Individuals aged less than 18 years old.
Those who refuse to participate in the study.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Collect peripheral blood and bronchoalveolar lavage fluid
Procedure/SurgeryPeripheral 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
ICU mortality
In ICU mortality
Time frame
up to 12 weeks2
hospital mortality
In hospital mortality
Time frame
up to 24 weeksSecondary outcomes
1
28 days without mechanical ventilation
28 days without mechanical ventilation
Time frame
up to 28 days2
length of stay in the ICU
length of stay in the ICU
Time frame
up to 12 weeks3
Total length of hospital stay
Total length of hospital stay
Time frame
up to 24 weeks4
Mortality at 1 year after discharge
Mortality at 1 year after discharge
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov