NCT00797433已完成不适用
Outcomes of Mechanically Ventilated Patients With Low Serum Testosterone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Serum testosterone level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Serum testosterone level
时间窗: Day 1, 3 and 7
次要结局
- Length of mechanical ventilation(Days)
研究者
研究点 (1)
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