Acute Respiratory Distress Syndrome
Conditions
Interventions
Observational group:None
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Patients with moderate to severe ARDS in acute phase, meeting the diagnostic criteria for moderate to severe ARDS: (1) Triggered by acute risk factors such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock. Pulmonary edema is not entirely or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities are not primarily attributable to atelectasis. However, ARDS may still be diagnosed in the presence of these conditions if predisposing risk factors for ARDS are present. (2) Acute onset or worsening of hypoxic respiratory failure within one week of anticipated or newly developed/worsening respiratory symptoms related to the risk factor. (3) Bilateral opacities on chest X-ray and/or CT, or bilateral B-lines and/or consolidation on ultrasound, not fully explainable by pleural effusion, atelectasis, or nodules/masses. (4) PaO2/FiO2 <= 200 mm Hg or SpO2/FiO2 <= 235 (if SpO2 <= 97%). 3. Intubation and mechanical ventilation initiated within 72 hours after onset of moderate to severe ARDS. 4. Enrollment occurs within 72 hours of ARDS onset (with onset time defined by medical record documentation). 5. The patient or their family member voluntarily participates in the study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation. 2. Brain death. 3. Genetic or acquired severe immunodeficiency, such as human immunodeficiency virus (HIV) infection, chronic granulomatous disease, or severe combined immunodeficiency. 4. Patient and/or legal representative has signed a do-not-resuscitate (DNR) order or has opted to withdraw treatment. 5. Currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilator-free days (VFDs) within 28 days;Levels of inflammatory and immune cell biomarker profiles in bronchoalveolar lavage fluid (BALF) in ARDS;Primary clinical study process indicators: Informed consent rate, recruitment rate, recruitment eligibility rate, protocol adherence, and follow-up completion rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality rate within 28 days, mortality rate within 90 days;ICU and hospital length of stay within 28 days after enrollment;Organ support-free days in 28 days; | — |
Countries
China
Contacts
Public ContactLong Yun
Peking Union Medical College Hospital
Outcome results
None listed