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Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00797433
First received: November 21, 2008
Last updated: September 20, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition
Acute Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Serum testosterone level [ Time Frame: Day 1, 3 and 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of mechanical ventilation [ Time Frame: Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: December 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mechanical ventilation
All male patients with acute respiratory failure requiring mechanical ventilation

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All adult male patients with acute respiratory failure on mechanical ventilation

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797433

Locations
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Solvay Pharmaceuticals
Investigators
Principal Investigator: Khalid F Almoosa, MD University of Texas
  More Information

No publications provided

Responsible Party: Khalid F. Almoosa, MD, University of Texas Health Science Center
ClinicalTrials.gov Identifier: NCT00797433     History of Changes
Other Study ID Numbers: GR-931
Study First Received: November 21, 2008
Last Updated: September 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
testosterone
mechanical ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 16, 2013