Bright Light Exposure in Patients Undergoing Non-cardiac Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change of Period 2 (Per2) protein levels
研究概览
简要总结
- Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery and with a decrease of Troponin I levels after surgery. In addition, we hypothesize that light therapy leads to Per2 dependent metabolic optimization in the human cardiac tissue. Therefore, a small piece of human heart tissue from the right atrium will be collected during cardiac cannulation, which will be otherwise discarded.
- Critical illness (being in the intensive care unit) results in circadian malfunction and vessels not working. Vessel function is controlled by the body's circadian clock. Intense light boosts the circadian clock and the vessel function in animal studies. Vessels not working well in critical ill patients results in a myriad of severe diseases (delirium, stroke, heart attack, organ damage etc). Thus we will test if intense light can be used to boost the circadian clock and the associated vessel function in critical ill patients.
详细描述
PER2 transcript and protein levels in patients undergoing cardiac surgery following intense light therapy utilizing blood samples, buccal swaps and right atrial myocardium. In addition, we will examine the correlation of PER2 levels and PER2 related metabolism and perform a whole genome microarray screen from the collected tissue/blood samples.
Patients will be enrolled 10 to 1 days prior to surgery and will either receive an intense (bright light) box or a placebo/control device (dim/night light box). The patient will start using the light box 7 days prior to surgery every morning from 8.30 to 9.00 AM. The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period.
- Blood /buccal swabs will be collected on the day of enrollment (10-1 days prior to surgery) between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of light/placebo therapy.
A small piece of the right atrial myocardium (which stems from cardiac cannulation and is otherwise discarded) will be put in liquid nitrogen in the OR and stored for further analysis.
In addition, we will draw a blood sample 72 hrs. after surgery and determine Troponin I levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary sternotomy cardiac surgery
- •Subjects in the range of 18 - 90 years old .
- •Patient need to be in sinus rhythm at the time of surgery.
排除标准
- •patients <18 or >90 years old
- •participation in other clinical trials within the previous 30 days
- •pregnancy
- •neurological conditions that could impair weaning from ventilator support
- •significant CNS disorders or comorbid irreversible conditions with a six-month mortality rate more than 50 percent
- •prisoners, or subjects with altered capabilities to make decision will be enrolled
- •medical history of type 2 diabetes
- •patients with atrial fibrillation or use of class III anti-arhythmic drug
- •patients with a left ventricle ejection fraction < 40%
- •patient in emergency condition
结局指标
主要结局
Change of Period 2 (Per2) protein levels
时间窗: 1-10 days
Measure of Per2 protein levels related to daylight exposure vs. room light exposure.
次要结局
未报告次要终点