Proof of Concept Trial to Confirm That the Recovery of Patients Treated in the Intensive Care Unit Requiring Mechanical Ventilation is Beneficially Affected by the Environmental Simulation of Daytime and Night Time Alternation as Well as by the Nutrition Protocol Corresponding to the Daily Rhythm
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change of the Multiple Organ Dysfunction Score value (delta MODS) from baseline to the end of the study treatment
研究概览
简要总结
The purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU) requiring mechanical ventilation.
详细描述
The homeostasis of human body is significantly disturbed when organs' work-relax periods are not harmonized. Intensive Care Unit (ICU) patient's circadian rhythm is almost inevitably upset as a result of their disease and/or medical intervention. There are numerous animal studies prove that circadian rhythm and periodic dynamics are directly related to healing time and hence, mortality rate. Although, one of the main messengers of circadian synchronization is melatonin, it is overridden by temperature, and a number of other factors from e.g. the digestive tract. If the circadian rhythm is disturbed, the function of different organ systems becomes desynchronized and chaotic.
ICU environment and patient-care activities brings major drawbacks as well mainly by necessary presence of noise and light. It has been shown that ICU settings have an impact on patients' sleep, which can easily lead to delirium and circadian disruption. There are significant data showing strong correlation between delirium and ICU length of stay/ mortality.
The focus of this study is the environmental modulation at the ICU with controlled light, noise and nutrition conditions. Controlled light conditions are created with artificial light during daytime and sleeping mask during night time. Earplugs are used during night time for controlled noise conditions. Nutrition is carried out only during daytime both in case of enteral and parenteral feeding.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years or older
- •Requiring treatment at the intensive care unit including mechanical ventilation
- •Admission at the intensive care unit was done within 24 hours before randomization
- •Written and signed patient information sheet and informed consent form obtained by the study participant or by his/her legal representative
排除标准
- •Traumatic brain injury
- •Multiple trauma
- •Severe damage of the eye/optic nerve
- •Blindness
- •Unlikely to survive 24 hours
- •Involvement of the central nervous system (trauma, bleeding, infection, ischemia, etc.)
- •Intracranial space occupying process
- •Increased intracranial pressure
- •Narcolepsy
- •Huntington's disease
- •Hypothermia
- •Pregnancy
研究组 & 干预措施
Controlled light, noise and nutrition
Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the nutrition protocol corresponding to the daily rhythm will be applied.
干预措施: Controlled light and noise (Other)
Controlled light, noise and nutrition
Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the nutrition protocol corresponding to the daily rhythm will be applied.
干预措施: Controlled nutrition (Other)
Controlled light and noise
Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the continuous nutrition (in accordance with the clinical trial site's standard practice) will be applied.
干预措施: Controlled light and noise (Other)
Control
The treatment of the study subject will be performed based on the clinical trial site's standard practice without environmental simulation or changes in the nutrition protocol.
结局指标
主要结局
Change of the Multiple Organ Dysfunction Score value (delta MODS) from baseline to the end of the study treatment
时间窗: Over the ICU treatment period but no more than 10 days
The primary efficacy endpoint is the change in MODS scale from baseline to the end of the study treatment period, i.e. deltaMODS. Since the length of ICU stay may be different for subjects, the MODS rate of change per day (deltaMODS/day) will be the primary measure to characterize the treatment effect.
次要结局
- Number of participants with delirium(over the ICU treatment period but no more than 10 days)
- Change of the MODS value (delta MODS) between worst and last score during the study treatment(Over the ICU treatment period but no more than 10 days)
- Number of participants with gastric retention(over the ICU treatment period but no more than 10 days)