跳至主要内容
临床试验/NCT02928887
NCT02928887撤回不适用

Light Therapy in Cardiopulmonary Bypass Surgery

University of Pittsburgh2 个研究点 分布在 1 个国家开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in creatinine concentration

研究概览

简要总结

The goal of this study is to determine whether or not exposure to blue spectrum light reduces acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary bypass. Subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to either bright (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light for a 24 hour photoperiod the day prior to surgery and for a 24 hour photoperiod in the immediate postoperative period.

详细描述

Light modifies the biology and physiology of mammals, including humans. The cellular biology of both the immune system, as well as, the cells comprising tissues and organs (e.g., kidney, liver) are under the regulation of light and exhibit circadian rhythms. Studies show that the severity of organ injury varies with the time of the day, the duration of the day, and the season. This variation is due to the biology of circadian rhythms, and light is the principle environmental cue entraining circadian biology. More recent data suggest that modulating the spectrum of light to which an organism is exposed may therapeutically modulate the cellular response to stress or injury. Specifically, exposure to a short (24 hour) photoperiod of high illuminance, blue spectrum light attenuated liver and kidney injury when animals were subjected to ischemia/reperfusion (I/R), a model in which the blood flow to an organ is temporarily reduced and then restored. A predominant cause of organ injury in this model is the misdirected and exacerbated inflammation of a type of immune cell called the neutrophil. However, blue light inhibited neutrophil infiltration into the ischemic kidney and liver, and thereby reduced inflammation and neutrophil-mediated organ injury.

Cardiopulmonary bypass (CPB) surgery is an operation characterized by excessive inflammation and a high risk of organ injury, particularly acute kidney injury (AKI). Thus, we hypothesize that exposure to blue light, by comparison to standard environmental, white fluorescent light, will reduce inflammation, organ injury and improve the outcome of patients undergoing CPB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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

入选标准

  • age greater than or equal to 18 years
  • undergoing cardiopulmonary bypass surgery

排除标准

  • Blindness
  • Immunocompromised or immunosuppressed state
  • Anticipated survival < 24 hours

结局指标

主要结局

Change in creatinine concentration

时间窗: Change in serum creatinine concentration at 24 hours after surgery compared to preoperative baseline creatinine concentration

The change in serum creatinine after intervention compared to baseline.

Change in blood urea nitrogen (BUN) concentration

时间窗: Change in serum BUN concentration at 24 hours after surgery compared to preoperative baseline BUN concentration

The change in serum BUN after intervention compared to baseline.

次要结局

  • Duration of renal replacement therapy(within 28 days after surgery)
  • Inflammation(Change in serum cytokine concentrations comparing serum concentrations at 24 hours after surgery to serum concentrations immediately (with 1 hour) after surgery)
  • all cause mortality(within 28 days after surgery)
  • duration of ICU stay(within 28 days after surgery)
  • duration of hospital stay(within 28 days after surgery)
  • Ventilator-free days(within 28 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Rosengart

Associate Professor

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验