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CompletedNCT00797433Updated Sep 21, 2010

Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

An observational study in Acute Respiratory Failure, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-21.

Sponsored by The University of Texas Health Science Center, Houston · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
28
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.
02

Conditions studied

  • Acute Respiratory Failure

Keywords

  • testosterone
  • mechanical ventilation
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 28 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult male patients with acute respiratory failure on mechanical ventilation

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
28 participants (estimated)

Groups and cohorts

  • Mechanical ventilation

    All male patients with acute respiratory failure requiring mechanical ventilation

06

What researchers measure

Primary outcomes

  1. Serum testosterone level

    Time frame: Day 1, 3 and 7

Secondary outcomes

  1. Length of mechanical ventilation

    Time frame: Days

07

Study locations

1 site
  • University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00797433
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
Solvay Pharmaceuticals
First posted
Nov 25, 2008
Start date
Dec 2008
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Sep 21, 2010

Study contacts

Khalid F Almoosa, MD
principal investigator · University of Texas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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