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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02509520
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 45 years
* Respiratory insufficiency requiring mechanical ventilation (MV)
* ICU presentation \< 6 days
* Patient or legally authorized representative able to provide written or witnessed verbal informed consent in English
* All four limbs intact and mobile
* Eligible for and able to participate in physical therapy
* Pre admission Barthel Index \>70
Exclusion Criteria:
* Acute kidney injury with a glomerular filtration rate \< 30 ml/min
* Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
* Diagnosis of active cancer
* Acute or chronic organ transplant rejection
* Exceedingly high mechanical ventilator settings (FiO2\>60%, PEEP\>12) or alternative modes of mechanical ventilation (inverse ratio pressure control, airway pressure release ventilation)
* Severe functional impairment or physical impairment to rehabilitation
* On high dose vasopressor agents (\> 5mcg of norepinephrine or equivalent)
* Liver function tests \> 2.5 x normal limits (normal reference ranges include AST between 10 and 40 units/L or ALT between 7 and 56 units/L)
* Chronic dementia or cognitive impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT02509520
Study Brief:
Protocol Section:
NCT02509520