Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

Study Overview
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Brief Summary
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This is a study to determine the testosterone serum levels in male patient with acute respiratory failure requiring mechanical ventilation. The objective is to determine if low levels exist in this population and if it correlates with length of mechanical ventilation. Hypothesis: Serum testosterone levels in mechanically ventilated male patients are significantly decreased from normal levels and correlate with disease severity and outcomes.

Detailed Description
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Study Objectives To confirm and quantify the presence of hypotestosteronemia in critically ill male patients with acute respiratory failure requiring mechanical ventilation via endotracheal intubation. To correlate serum testosterone levels with disease severity, short-term outcomes, and survival in mechanically ventilated male patients. To determine if demographic patient characteristics, such as age, admitting diagnosis, or the presence of co-morbidities, affect serum testosterone levels during mechanical ventilation.

Official Title
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Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

Conditions
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Acute Respiratory Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Age > 18 Admission diagnosis of acute respiratory failure requiring endotracheal intubation and mechanical ventilation for > 24 hours APACHE II score > 15 (APACHE: Acute Physiology and Chronic Health Evaluation - general indicator of disease severity and outcomes predictor) Exclusion Criteria: Chronic mechanical ventilation (i.e. patients on mechanical ventilatory support for > 21 days for at least 6 hours per day) Patients on mechanical ventilation for > 48 hours prior to MICU admission Non-invasive mechanical ventilation Patients intubated and mechanically ventilated for drug overdose and anticipated to be intubated for < 24 hours Known diagnosis of hypogonadism (requiring testosterone hormonal supplementation) or currently receiving testosterone therapy or received testosterone therapy within 30 days of MICU admission History of testicular, prostate or pituitary tumor Chronic use of systemic steroids prior to admission Terminally ill patients who are not expected to live longer that 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mechanical ventilation<br>All male patients with acute respiratory failure requiring mechanical ventilation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum testosterone level |  | Day 1, 3 and 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of mechanical ventilation |  | Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testosterone, mechanical ventilation