Evaluation of Specific Light Algorithms to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in serum melatonin concentration
研究概览
简要总结
The purpose of this prospective, randomized controlled trial is to investigate if mechanically ventilated patients who are treated with a Light Scheduling Algorithm with high circadian effective irradiances are better able to preserve and induce physiological melatonin rhythms compared to patients who are treated with an application of lower irradiances.
The investigators will further evaluate the impact on delirium prevalence, stress level and general outcome parameters.
详细描述
Circadian disruption affects the majority of ICU patients and has far-reaching effects on organ functioning. At the level of the central nervous system, circadian misalignment facilitates executive cognitive dysfunction and the development of brain disorders such as ICU delirium.
The suprachiasmatic nucleus (SCN) in the hypothalamus serves as the master pacemaker that sets the timing of circadian rhythms by regulating neuronal activity. Its function is determined by environmental factors, especially visible light with a high content of blue light components. Light as a photoperiodic signal has a great impact on the regulation of the epiphyseal melatonin secretion and the entrainment of the day-night rhythm. As a result using light therapy to maintain or entrain circadian rhythm seems to be a promising approach to prevent delirium in critically ill patients. The specific light effect on the rhythmicity of the melatonin levels is to be examined in a randomized controlled study design, which includes the application of three different Light Scheduling Algorithms. In this context a highly specialized light ceiling was installed in two patient treatment rooms. A Light Scheduling Algorithm (LSA) consists of specified values for illuminance [lux] and correlated color temperature (CCT, [kelvin]) for different time points and durations within a 24-hour period. These values are calculated by assessment of photometric light measures with regard to visual light effects as well as non-image-forming functions at the patients bedside.
Patients will be randomly allocated in to 3 treatment groups: (1) LSA-1 (high circadian effective irradiances + blue Light Intervention), (2) LSA-2 (high circadian effective irradiances without blue light intervention) and (3) LSA-3 (standard irradiances, Control Group). All LSAs will be applied to the patient using VitalSky Advanced. For the purpose of validation of efficacy of specific light interventions, blood samples for measurement of melatonin concentration will be collected.
The temporal study sequence is defined by treatment days and measurement series periods (SMAP-1 to SMAP-4, Serum Melatonin Assessment Period). SMAP-1 starts on the first morning at 06:00 a.m. after study inclusion. SMAP-1 through SMAP-4 each define 24-hour periods in which the blood melatonin concentration is determined every 4 hours (6 am, 10 am, 2 pm, 6 pm, 10 pm, 2 am, 6 am). The SMAP-1 is intended to determine the patient's individual melatonin baseline. SMAP-2 to SMAP-4 start only when the patient has reached a stable level of wakefulness (RASS ≥-3 ). It can be assumed that the light intervention will only have an effect on melatonin balance from this level of wakefulness. A total of 4 SMAPs are planned per study patient.
Main Hypothesis:
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 110 Years（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/authorized 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 ≥ 5 days
- •Invasive mechanical ventilation or non-invasive mechanical ventilation (with positive ventilation pressure > 6 hours/day or high flow >30 liters) on the day of ICU admission
排除标准
- •Participation in other clinical studies during the study period and ten days before
- •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
- •Analphabetism
- •Anacusis or Hypoacusis with hearing aid device, Amaurosis
- •Lacking willingness to save and hand out data within the study
- •Accommodation in an institution due to an official or judicial order
- •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
- •Patients with an open chest after cardiac surgery
- •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
- •Severe eye diseases
- •History of photoallergic reactions
- •History of visually triggered seizures
- •Termination criteria:
- •Under the following conditions, premature withdrawal of a Patient from the study according to the termination criteria will occur:
- •Personal request of the patient/caregiver/authorized representative.
- •Any other situation in which, in the opinion of the study physician, continued participation in the clinical trial is not in the best interest of the of the patient
- •Subsequent occurrence of an exclusion criterion
- •Premature termination of the study or discontinuation of the entire study may be considered because of the following circumstances:
- •Decision of the principal investigator in case of unacceptable risks under Benefit-risk consideration
- •New (scientific) findings during the term of the clinical study that may compromise the safety of the study participants (positive risk-benefit balance no longer given).
结局指标
主要结局
Change in serum melatonin concentration
时间窗: Plasma melatonin levels will be assessed for a maximum of five 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. (6am, 10am, 2pm, 6pm, 10pm, 2am, 6am).
Prevalence of physiological circadian rhythmicity measured by serum melatonin concentrations
次要结局
- Depth of Sedation(Participants will be followed up to 6 days after intensive care unit admission)
- Duration of mechanical and non-mechanical ventilation(Participants will be followed up until ICU discharge)
- ICU length of stay(Participants will be followed up until ICU discharge)
- Hospital length of stay(Participants will be followed up until hospital discharge)
- Severity of Pain(Participants will be followed up to 6 days after intensive care unit admission)
- Prevalence of intensive care unit delirium(Participants will be followed up to 6 days after intensive care unit admission)
- Delirium Severity(Participants will be followed up to 6 days after intensive care unit admission)
- Patient comfort(Participants will be followed up to 6 days after intensive care unit admission)
- Septic Shock(Participants will be followed up to 6 days after intensive care unit admission)
- Simplified Acute Physiology Score (SAPS II)(Participants will be followed up to 6 days after intensive care unit admission)
- Sepsis(Participants will be followed up to 6 days after intensive care unit admission)
- Therapeutic Intervention Scoring System (TISS-28)(Participants will be followed up to 6 days after intensive care unit admission)
- Acute Physiological and Chronic Health Evaluation 2 Score (APACHE II)(Participants will be followed up to 6 days after intensive care unit admission)
- Sequential Organ Failure Assessment (SOFA-Score)(Participants will be followed up to 6 days after intensive care unit admission)
研究者
Alawi Luetz
Prof. Dr. med.
Charite University, Berlin, Germany