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临床试验/NCT00470821
NCT00470821已完成4 期

Randomized, Controlled, Double Blind Trial to Evaluate Sedation and Quality of Life in High-risk, Critically Ill Patients Treated With Oral Melatonin

University of Milan1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
96
试验地点
1
主要终点
Overall sedatives daily doses

研究概览

简要总结

Sleep disruptions are extremely common in high-risk critically ill patients. The investigators want to analyse oral melatonin potentialities as a sedative and a free-radicals scavenger for critically ill patients, and secondarily for preventing Delirium during their ICU stay and post-traumatic stress disorders after ICU discharge.

详细描述

The physiological secretion of such melatonin follows a circadian rhythm: melatonin plasma concentration increases with the dark reaching a peak around to midnight and then gradually decreases (Reiter, 1996; Shigeta et al., 2001; Kunz et al., 2004; Brzezinski et al., 2005).

Administration of oral melatonin could be useful in critically ill high-risk patients in Intensive Care Units because these patients are often suffering from sleep disturbances (Weber et al., 1985; Bourne and Mills, 2004) possibly because of:

  • presence of underlying pathology with pain and anxiety,
  • presence of oral or nasal respiratory prosthesis,
  • execution of therapeutic procedures on 24 h. Moreover it has been demonstrated that in ICU patients melatonin rhythm is desynchronized (Bourne and Mills, 2000). This is probably related to sedation and-or mechanical ventilation. Furthermore, it has been showed that melatonin is a powerful anti-oxidant, therefore it could be potentially useful in critical patients usually characterized by increased production of oxygen free radicals.

AIM OF THE STUDY The study is aimed to estimate if the administration of oral melatonin in ICU patients is able to regularize the sleep-waking rhythm, improving sleep quality and reducing episodes of agitation/mental confusion. The main objectives are: assessment of sleep quality, prevalence of mental confusion/agitation, amount of daily sedative drugs administered and modification of redox status.

ENROLLMENT OF PATIENTS At the admission in ICU, obtained the informed consent, the patients will be randomly assigned to the "Treatment" group receiving melatonin 3mg BID by oral route (or nasogastric tube) or to the "Control" group receiving placebo. The sedation will be performed according to clinical standard.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • High Treatment > 1 day
  • Normal gastrointestinal function

排除标准

  • Status asthmaticus
  • Chronic renal failure under dialytic treatment
  • Severe hepatopathy (Child-Pugh class = C)
  • Comatous patients (GCS < 12)
  • Head trauma, severe neurological diseases (ictus cerebri, SAH, ...)
  • Intoxicated patients

研究组 & 干预措施

A - placebo

Placebo Comparator

Identical tablets without the active principles. Each evening, nurses are requested to give 2 tablets at 8 PM and 12 PM

干预措施: Placebo (Drug)

B - melatonin

Active Comparator

Identical tablets containing melatonin 3 mg Nurses are requested to give two tablets daily, at 8 PM and 12 PM.

干预措施: Oral melatonin 3mg BID (Drug)

结局指标

主要结局

Overall sedatives daily doses

时间窗: Discharge from ICU

次要结局

  • Prevalence of Delirium assessed with CAM-ICU(Discharge from ICU)
  • Prevalence of mental disorders(60 days after ICU discharge)
  • ICU length of stay(Discharge from ICU)
  • ICU mortality(Discharge from ICU)
  • Hospital mortality(Hospital discharge)
  • Sleep quantity assessed by wrist actigraphy(Discharge from ICU)

研究者

申办方类型
Other

研究点 (1)

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