Light Therapy in Cardiopulmonary Bypass Surgery

Not Applicable

Withdrawn

• Conditions: Inflammation; Acute Kidney Injury
• Interventions: Other: Blue light

• Registration Number: NCT02928887
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Study Start: 2020-09-01
• Status Verified: 2022-01
• Primary Completion: 2022-01-19
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blue light	Blue light	Exposure to high illuminance (1000 lux), blue spectrum (480nm) light for the 24 hour photoperiod prior to surgery and for the 24 hour photoperiod immediately after surgery

Primary Outcome Measures

Name	Time	Method
Change in creatinine concentration	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	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.

Secondary Outcome Measures

Name	Time	Method
Duration of renal replacement therapy	within 28 days after surgery	Days of dialysis within the first 28 days after surgery and intervention
Inflammation	Change in serum cytokine concentrations comparing serum concentrations at 24 hours after surgery to serum concentrations immediately (with 1 hour) after surgery	The change in serum concentration of inflammatory mediators after intervention compared to baseline.
all cause mortality	within 28 days after surgery	Death 28 days after surgery and intervention
duration of ICU stay	within 28 days after surgery	ICU length of stay 28 days after surgery and intervention
duration of hospital stay	within 28 days after surgery	Hospital length of stay 28 days after surgery and intervention
Ventilator-free days	within 28 days after surgery	Cumulative days without mechanical ventilation 28 days after surgery and intervention

Trial Locations

Locations (1)

Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States