Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone

This study is not yet open for participant recruitment.

Verified by The University of Texas Health Science Center, Houston, November 2008

Sponsors and Collaborators:	The University of Texas Health Science Center, Houston Solvay Pharmaceuticals
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00797433

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

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	28
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (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

To confirm and quantify the presence of hypotestosteronemia in critically ill male patients with acute respiratory failure requiring mechanical ventilation via endotracheal intubation.
To correlate serum testosterone levels with disease severity, short-term outcomes, and survival in mechanically ventilated male patients.
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:

Male
Age > 18
Admission diagnosis of acute respiratory failure requiring endotracheal intubation and mechanical ventilation for > 24 hours
APACHE II score > 15 (APACHE: Acute Physiology and Chronic Health Evaluation - general indicator of disease severity and outcomes predictor)

Exclusion Criteria:

Chronic mechanical ventilation (i.e. patients on mechanical ventilatory support for > 21 days for at least 6 hours per day)
Patients on mechanical ventilation for > 48 hours prior to MICU admission
Non-invasive mechanical ventilation
Patients intubated and mechanically ventilated for drug overdose and anticipated to be intubated for < 24 hours
Known diagnosis of hypogonadism (requiring testosterone hormonal supplementation) or currently receiving testosterone therapy or received testosterone therapy within 30 days of MICU admission
History of testicular, prostate or pituitary tumor
Chronic use of systemic steroids prior to admission
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

Contacts

Contact: Khalid F Almoosa, MD

7135006839

khalid.f.almoosa@uth.tmc.edu

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

Responsible Party:	University of Texas Health Science Center ( Khalid F. Almoosa, MD )
Study ID Numbers:	GR-931
Study First Received:	November 21, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797433
Health Authority:	United States: Institutional Review Board

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

testosterone
mechanical ventilation

Study placed in the following topic categories:

Testosterone
Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome
Methyltestosterone
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 15, 2009