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Completed

NCT Number: NCT00797433

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum testosterone level

    Time frame: Day 1, 3 and 7

Secondary outcomes

  1. Length of mechanical ventilation

    Time frame: Days

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Solvay Pharmaceuticals

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2008
Registry last updated
Sep 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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