NCT05807178招募中不适用
Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rhythmicity of melatonin concentration
研究概览
简要总结
The investigators will examine the effects of dynamic light therapy on circadian rhythms in delirious intensive care unit (ICU) patients. In a randomized controlled trial (RCT), they will investigate the effects of a specific light algorithm on rhythms of serum melatonin, clock gene expression, the proteome, and metabolome, compared to standard hospital lighting, supported by the data science algorithms to improve vital-based algorithms with light interventions.
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
- •Patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in the intensive care unit
- •Male and female patients with age ≥ 18 years
- •Expected intensive care unit stay ≥ 2 days
- •Positive delirium during and up to a maximum of 30 days after study inclusion (determined by CAM-ICU, at least once per shift)
排除标准
- •Participation in other clinical studies during the study period and ten days before
- •Previous ICU treatment during the current hospital stay
- •Patients with psychiatric diseases
- •Patients with a history of stroke and known severe residual cognitive deficits
- •Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay
- •Amaurosis
- •History of sleep-related breathing disorders
- •History or suspicion of hypoxic brain damage
- •History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion
- •Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
- •The informed consent of the patient or the subject's legally acceptable representative can't be obtained in time
- •History of photoallergic reactions or history of visually triggered seizures
- •Severe eye diseases (e.g. retinopathy, glaucoma) or high sensitivity to bright light
- •Patients with liver cirrhosis
- •Patients with a probability of survival <24h
- •Optic neuritis within the last 3 months
- •Travel across two time zones within 3 months prior to study screening
- •Women who are pregnant, have a positive pregnancy test, are breastfeeding or plan to become pregnant during the course of this clinical trial
- •Therapy-refractory blood coagulation disorder and inability to consent are exclusion criteria for a muscle biopsy
研究组 & 干预措施
LSA-1
Experimental
Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances
干预措施: Dynamic Light Therapy Device, LSA-1 (Device)
LSA-2
Active Comparator
Light Scheduling Algorithm-2 (LSA-2): Irradiance levels comparable to conventional hospital lighting (control group).
干预措施: Dynamic Light Therapy Device, LSA-2 (Device)
结局指标
主要结局
Rhythmicity of melatonin concentration
时间窗: Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations.
次要结局
- Incidence of intensive care unit delirium(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Depth of Sedation(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Level of analgesia 2(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Total amount of sedatives(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- ICU length of stay(Participants will be followed up until ICU discharge, an expected average of 3 days.)
- Sepsis(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Sequential Organ Failure Assessment (SOFA-Score)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Simplified Acute Physiology Score (SAPS II)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Medical Research Council (MRC) Score(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Hand strength measurements(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- FIM Score (Functional Independence Measure)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Mean blood glucose (mg/dl)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Delirium-free days in the intensive care unit(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Delirium Severity(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Level of analgesia 1(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Level of analgesia 3(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Level of analgesia 4(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Level of analgesia 5(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Total amount of opioids(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Duration of ventilation(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Hospital length of stay(Participants will be followed up until hospital dischargean expected average of 7 days.)
- Septic shock(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Therapeutic Intervention Scoring System (TISS-28)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Acute Physiological and Chronic Health Evaluation 2 Score (APACHE II)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Intensive Care Mobility Scale(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Blood glucose variability (SD in mg/dl)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Percentage of time in target glucose range (%)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Insulin requirement (IU/kg/h)(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Analysis of the sleep architecture measured by polysomnography 2(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Clock genes(Clock gene expression levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion.)
- Metabolomics(Metabolomic measurements be assessed up to 3 (6-9) months.)
- Proteomics(Proteomic measurements will be assessed up to 3 (6-9) months.)
- Inflammation parameters(Inflammation parameter levels will be assessed up to 3 (6-9) months.)
- Post Intensive Care Syndrome (PICS)(Up to 3 (6-9) months)
- Analysis of the sleep architecture measured by polysomnography 1(Up to 3 (6-9) months)
- MCTQ (Munich Chronotype Questionnaire)(Up to 3 (6-9) months)
- Actigraphy(Up to 3 (6-9) months)
- Sleep diary(Up to 3 (6-9) months)
- Molecular data(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Physiotherapy(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Nutritional Therapy(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Nutritional Therapy Complications(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Target protein intake(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Adherence to the diet plan(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Composition of the administered food(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Daily feeding breaks(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Wheather data(Participants will be followed up until discharge from the intensive care unit (maximum up to day 5))
- Cognition 1(Up to 3 (6-9) months)
- Cognition 2(Up to 6 months)
- Cognition 3(Up to 3 (6-9) months)
- Mental impairments(Up to 3 (6-9) months)
- Quality of life 1(Up to 3 (6-9) months)
- Quality of life 2(Up to 3 (6-9) months)
- Mortality(Up to 6 months)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
Charite University, Berlin, Germany
研究点 (2)
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