Clinical trial NCT02928887: Light Therapy in Cardiopulmonary Bypass Surgery
Official title: Light Therapy in Cardiopulmonary Bypass Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Kidney Injury
Inflammation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Blindness
* Immunocompromised or immunosuppressed state
* Anticipated survival \< 24 hours

Primary outcomes:
measure: Change in creatinine concentration
timeFrame: Change in serum creatinine concentration at 24 hours after surgery compared to preoperative baseline creatinine concentration
measure: Change in blood urea nitrogen (BUN) concentration
timeFrame: Change in serum BUN concentration at 24 hours after surgery compared to preoperative baseline BUN concentration
Secondary outcomes:
measure: Inflammation
timeFrame: Change in serum cytokine concentrations comparing serum concentrations at 24 hours after surgery to serum concentrations immediately (with 1 hour) after surgery
measure: all cause mortality
timeFrame: within 28 days after surgery
measure: duration of ICU stay
timeFrame: within 28 days after surgery
measure: duration of hospital stay
timeFrame: within 28 days after surgery
measure: Ventilator-free days
timeFrame: within 28 days after surgery
measure: Duration of renal replacement therapy
timeFrame: within 28 days after surgery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Matthew R Rosengart, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuan D, Collage RD, Huang H, Zhang X, Kautza BC, Lewis AJ, Zuckerbraun BS, Tsung A, Angus DC, Rosengart MR. Blue light reduces organ injury from ischemia and reperfusion. Proc Natl Acad Sci U S A. 2016 May 10;113(19):5239-44. doi: 10.1073/pnas.1515296113. Epub 2016 Apr 25.
citation: Castro RA, Angus DC, Hong SY, Lee C, Weissfeld LA, Clermont G, Rosengart MR. Light and the outcome of the critically ill: an observational cohort study. Crit Care. 2012 Jul 24;16(4):R132. doi: 10.1186/cc11437.