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 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT00797433
Eligibility Criteria:
Inclusion Criteria:
1. Male
2. Age \> 18
3. Admission diagnosis of acute respiratory failure requiring endotracheal intubation and mechanical ventilation for \> 24 hours
4. APACHE II score \> 15 (APACHE: Acute Physiology and Chronic Health Evaluation - general indicator of disease severity and outcomes predictor)
Exclusion Criteria:
1. Chronic mechanical ventilation (i.e. patients on mechanical ventilatory support for \> 21 days for at least 6 hours per day)
2. Patients on mechanical ventilation for \> 48 hours prior to MICU admission
3. Non-invasive mechanical ventilation
4. Patients intubated and mechanically ventilated for drug overdose and anticipated to be intubated for \< 24 hours
5. Known diagnosis of hypogonadism (requiring testosterone hormonal supplementation) or currently receiving testosterone therapy or received testosterone therapy within 30 days of MICU admission
6. History of testicular, prostate or pituitary tumor
7. Chronic use of systemic steroids prior to admission
8. Terminally ill patients who are not expected to live longer that 3 months
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00797433
Study Brief:
Protocol Section:
NCT00797433