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Light Therapy in Cardiopulmonary Bypass Surgery

Light Therapy in Cardiopulmonary Bypass Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02928887
Enrollment
0
Registered
2016-10-10
Start date
2020-09-01
Completion date
2022-06-30
Last updated
2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Inflammation

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.

Interventions

Exposure to high illuminance (1000 lux), blue spectrum (480 nm) light for a 24-hour photoperiod immediately before surgery and a 24-hour photoperiod immediately after surgery

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in creatinine concentrationChange in serum creatinine concentration at 24 hours after surgery compared to preoperative baseline creatinine concentrationThe change in serum creatinine after intervention compared to baseline.
Change in blood urea nitrogen (BUN) concentrationChange in serum BUN concentration at 24 hours after surgery compared to preoperative baseline BUN concentrationThe change in serum BUN after intervention compared to baseline.

Secondary

MeasureTime frameDescription
duration of ICU staywithin 28 days after surgeryICU length of stay 28 days after surgery and intervention
duration of hospital staywithin 28 days after surgeryHospital length of stay 28 days after surgery and intervention
InflammationChange in serum cytokine concentrations comparing serum concentrations at 24 hours after surgery to serum concentrations immediately (with 1 hour) after surgeryThe change in serum concentration of inflammatory mediators after intervention compared to baseline.
Duration of renal replacement therapywithin 28 days after surgeryDays of dialysis within the first 28 days after surgery and intervention
Ventilator-free dayswithin 28 days after surgeryCumulative days without mechanical ventilation 28 days after surgery and intervention
all cause mortalitywithin 28 days after surgeryDeath 28 days after surgery and intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026