Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

Acute Respiratory Failure Clinical Trial

Official title:

Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797433
• Other study ID #: GR-931
• Status: Completed
• Phase: N/A
• First received: November 21, 2008
• Last updated: September 20, 2010
• Start date: December 2008
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum testosterone level		Day 1, 3 and 7	No
Secondary	Length of mechanical ventilation		Days	No