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临床试验/NCT05342987
NCT05342987已完成不适用

The Relationship Between Delirium and Circadian Rhythm in Intensive Care Unit

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
190
试验地点
1
主要终点
Changes of melatonin level

研究概览

简要总结

The study aims to investigate the status of circadian rhythm and sleep quality in ICU patients and their influence factors. And explore the pathway of circadian rhythm on ICU delirium.

The hypothesis of study is that icu patients experience circadian and sleep rhythm disorder, especially in patient who have delirium.

详细描述

Delirium is an acute and fluctuating alteration of mental state characterized by a disturbance in attention, level of consciousness and cognition. At present, there is no unified conclusion on the pathogenesis of delirium. There are many different hypotheses, such as the neuroinflammation hypothesis, the neuronal aging hypothesis, the oxidative stress hypothesis, the neurotransmitter hypothesis, the neuroendocrine hypothesis and the circadian rhythm disturbance hypothesis. Among them, the circadian rhythm disturbance hypothesis believes that the circadian rhythm disorder caused by various reasons, which leads to sleep disturbance and melatonin secretion disorder promotes the occurrence of acute cognitive impairment, which in turn leads to the occurrence of delirium. Circadian rhythm refers to the rhythm of any biological process in the human body that repeats and maintains within 24 hours without external stimulation. By far, the most common way to measure circadian rhythm is through vital signs rhythms, hormone secretion (cortisol and melatonin levels), and sleep-wake cycle.

Due to the special environment and treatment needs in ICU make patients' circadian rhythm easily broken, and produced a large latent harm to patients. Most studies are in the process of delirium and sleep research, selecting a small subgroup to evaluate the circadian rhythm indicators of patients, and the overall relationship between delirium and circadian rhythm is not clear.

Thus, the study aims to investigate the status of circadian rhythm and sleep quality in ICU patients and their influence factors, and explore the pathway of circadian rhythm action on ICU delirium.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Aged above 18

排除标准

  • History of mental or psychological illness
  • The patient remained in coma or deep sedation
  • Delirium was occurring at the time of admission
  • Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese
  • Neurosurgery and maternal patients

结局指标

主要结局

Changes of melatonin level

时间窗: Three time a day in 3, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICU

Test Serum melatonin level

Sleep Quality

时间窗: up to 14 days after admission in ICU

Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire

Changes of cortisol level

时间窗: Three time a day in 0, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICU

Test Serum cortisol level

次要结局

  • ICU delirium(up to 14 days after admission in ICU)
  • patient outcome(up to 14 days after admission in ICU)
  • LOS(up to 14 days after admission in ICU)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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