Viewing Study NCT00797433


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Study NCT ID: NCT00797433
Status: COMPLETED
Last Update Posted: 2010-09-21
First Post: 2008-11-21
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone
Sponsor: The University of Texas Health Science Center, Houston
Organization:

Study Overview

Official Title: Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone
Status: COMPLETED
Status Verified Date: 2010-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 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: 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 intubation.
2. To correlate serum testosterone levels with disease severity, short-term outcomes, and survival in mechanically ventilated male patients.
3. To determine if demographic patient characteristics, such as age, admitting diagnosis, or the presence of co-morbidities, affect serum testosterone levels during mechanical ventilation.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: