Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
NCT ID:
NCT01731795
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old
* Patients must have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS: (i) having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.; (ii) bilateral infiltrates on frontal chest radiograph; (iii) absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure; (iv) severe hypoxemia (a PaO2/FIO2 \<200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)
* Be intubated and mechanically ventilated
* Have provided signed written informed consent from the patient or the patient's personal legal representative
Exclusion Criteria:
* Be a woman known to be pregnant or lactating
* Take part in another experimental treatment protocol (simultaneously)
* Brain death
* Terminal-stage cancer or other terminal disease
* Having do-not-resuscitate orders
* Being immune-compromised
* Receiving corticosteroids or immunosuppressive drugs
* Patients in whom more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.
* Have severe chronic obstructive pulmonary disease (COPD)
* Have congestive heart failure
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01731795
Study Brief:
Protocol Section:
NCT01731795