Status:
COMPLETED
Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Acute Respiratory Failure
Eligibility:
MALE
18+ years
Brief Summary
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 po...
Detailed Description
Study Objectives 1. To confirm and quantify the presence of hypotestosteronemia in critically ill male patients with acute respiratory failure requiring mechanical ventilation via endotracheal intuba...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00797433
Start Date
December 1 2008
End Date
August 1 2010
Last Update
September 21 2010
Active Locations (1)
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1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030