Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure

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 Type: Observational
• Enrollment (Anticipated): 28

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

All adult male patients with acute respiratory failure on mechanical ventilation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Mechanical ventilation; All male patients with acute respiratory failure requiring mechanical ventilation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of mechanical ventilation	Days

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Solvay Pharmaceuticals
• Investigators: Principal Investigator: Khalid F Almoosa, MD, University of Texas

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: November 21, 2008
• First Submitted That Met QC Criteria: November 24, 2008
• First Posted (Estimate): November 25, 2008

Study Record Updates

• Last Update Posted (Estimate): September 21, 2010
• Last Update Submitted That Met QC Criteria: September 20, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: mechanical ventilation; testosterone
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: GR-931