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 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT00562835
Eligibility Criteria:
Inclusion Criteria:
* Age. Patients age 18 years or older admitted to the intensive care unit.
* ALI/ARDS criteria. The diagnosis of ALI/ARDS requires all of the following criteria:
* Respiratory failure requiring mechanical ventilation - via endotracheal intubation or noninvasive positive pressure ventilation
* Acute onset of bilateral pulmonary densities on chest radiograph in the contest of appropriate predisposing injury or illness with no evidence of left ventricular failure,
* Static pulmonary compliance \< 50 cm H2O
* Ratio of partial pressure of arterial oxygen to partial pressure of alveolar oxygen (PaO2:FiO2 ) equal or less than 300 (criteria for ALI) or 200 (criteria for ARDS) with FiO2 1.0.
* Severe ARDS. PaO2:FiO2 equal or less than 200 after 30 minutes of standardized ventilatory management on PEEP of 10 cm H2O with FiO2 1.0.
Exclusion Criteria:
* Failure to obtain written informed consent from the patient or a next of kin.
* Trauma-induced ARDS.
* Major gastrointestinal bleeding requiring transfusion of 5 units or more of packed red blood cells (PRBC) within 3 months current hospitalization
* Condition requiring \> 0.5mg/Kg/day of prednisone equivalent (i.e., acute asthma or chronic obstructive pulmonary disease \[COPD\])
* Patients enrolled in another experimental (interventional) protocol within the past 30 days, which might adversely impact on the results of this study as determined by the investigators
* Pregnancy confirmed by urine or serum test
* Weight is \> 200% of ideal body weight
* Non-ambulatory resident of long-term care facility
* Primary care physician not committed to full, aggressive support of the patient at the time of randomization
* Moribund patient (i.e., not expected to live more than 24 hr) or with recent (within 7 days or anytime during present hospitalization) cardiopulmonary arrest
* Known or suspected irreversible cessation of all brain function
* Presence of preexisting medical condition which is irreversible and expected to be fatal within 3 months
* Immunosuppression including HIV+ status, history of bone marrow or solid organ transplantation, current malignancy, neutropenia, receiving cytotoxic therapy for any reason, and acute burn injury
* Severe chronic liver disease (Child-Pugh Class C score \> 10 points)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00562835
Study Brief:
Protocol Section:
NCT00562835