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Light Therapy in Cardiopulmonary Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928887
Recruitment Status : Suspended (Cardiac surgeon collaborator has left the institution)
First Posted : October 10, 2016
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew Rosengart, 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Inflammation Other: Blue light Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Light Therapy in Cardiopulmonary Bypass Surgery
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: 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
Other: Blue light
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

No Intervention: Ambient light
Exposure to ambient, white fluorescent light



Primary Outcome Measures :
  1. Change in creatinine concentration [ Time Frame: 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.

  2. Change in blood urea nitrogen (BUN) concentration [ Time Frame: 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 :
  1. Inflammation [ Time Frame: 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.

  2. all cause mortality [ Time Frame: within 28 days after surgery ]
    Death 28 days after surgery and intervention

  3. duration of ICU stay [ Time Frame: within 28 days after surgery ]
    ICU length of stay 28 days after surgery and intervention

  4. duration of hospital stay [ Time Frame: within 28 days after surgery ]
    Hospital length of stay 28 days after surgery and intervention

  5. Ventilator-free days [ Time Frame: within 28 days after surgery ]
    Cumulative days without mechanical ventilation 28 days after surgery and intervention

  6. Duration of renal replacement therapy [ Time Frame: within 28 days after surgery ]
    Days of dialysis within the first 28 days after surgery and intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928887


Locations
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United States, Pennsylvania
Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Matthew R Rosengart, MD MPH University of Pittsburgh
Publications:
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Responsible Party: Matthew Rosengart, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02928887    
Other Study ID Numbers: PRO16090192
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases