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临床试验/NCT00405847
NCT00405847已完成4 期

A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients

University of Arizona2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2006年7月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
17
试验地点
2
主要终点
Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)

研究概览

简要总结

The purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.

详细描述

Over 1 million patients receive mechanical ventilation every year in the United States. In mechanically ventilated patients, despite sedative infusions, sleep is severely disrupted. Sleep disruption, in turn, can lead to activation of sympathetic nervous system and elevated inflammatory cytokines. Both sympathetic hyperactivity and elevated cytokines have been associated with delirium, which, in turn, is associated with increased mortality and higher healthcare costs. Currently, however, there is very little understanding of the inter-relationship between critical illness, sleep, and neuropsychological well-being. The purpose of this study is to collect preliminary data on the short-term effects of sedation with and without sympatholysis on sleep and inflammation in critically ill patients receiving mechanical ventilation. This pilot study will be accomplished by performing sleep studies and circulating cytokine measurements in critically ill patients randomized to receive two different sedation strategies: Dexmedetomidine versus Midazolam and Fentanyl. The ultimate goal of this program of research is to identify sedation practices that are least associated with adverse short- and long-term consequences, and thereby ultimately help improve sleep quality and quality of life in patients surviving critical illness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring mechanical ventilation with a diagnosis of
  • Acute Respiratory Distress Syndrome
  • Cardiogenic Pulmonary Edema
  • Pneumonia
  • Chronic obstructive pulmonary disease

排除标准

  • Patients who are considered too unstable to undergo this investigation by their primary physician
  • Comatose patients, or patients with severe debilitating neurological disease
  • Renal insufficiency (Sr. Creatinine > 2 mg/dL)
  • Heart block (second or third degree heart block) or sinus bradycardia (heart rate < 60 beats per minute)
  • Pregnancy

结局指标

主要结局

Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)

Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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