Light Therapy in Cardiopulmonary Bypass Surgery
Primary Purpose
Acute Kidney Injury, Inflammation
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blue light
Sponsored by
About this trial
This is an interventional basic science trial for Acute Kidney Injury
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
Sites / Locations
- Presbyterian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Blue light
Ambient light
Arm Description
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
Exposure to ambient, white fluorescent light
Outcomes
Primary Outcome Measures
Change in creatinine concentration
The change in serum creatinine after intervention compared to baseline.
Change in blood urea nitrogen (BUN) concentration
The change in serum BUN after intervention compared to baseline.
Secondary Outcome Measures
Inflammation
The change in serum concentration of inflammatory mediators after intervention compared to baseline.
all cause mortality
Death 28 days after surgery and intervention
duration of ICU stay
ICU length of stay 28 days after surgery and intervention
duration of hospital stay
Hospital length of stay 28 days after surgery and intervention
Ventilator-free days
Cumulative days without mechanical ventilation 28 days after surgery and intervention
Duration of renal replacement therapy
Days of dialysis within the first 28 days after surgery and intervention
Full Information
NCT ID
NCT02928887
First Posted
October 5, 2016
Last Updated
January 19, 2022
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT02928887
Brief Title
Light Therapy in Cardiopulmonary Bypass Surgery
Official Title
Light Therapy in Cardiopulmonary Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Cardiac surgeon collaborator has left the institution
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
January 19, 2022 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blue light
Arm Type
Experimental
Arm Description
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
Arm Title
Ambient light
Arm Type
No Intervention
Arm Description
Exposure to ambient, white fluorescent light
Intervention Type
Other
Intervention Name(s)
Blue light
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in creatinine concentration
Description
The change in serum creatinine after intervention compared to baseline.
Time Frame
Change in serum creatinine concentration at 24 hours after surgery compared to preoperative baseline creatinine concentration
Title
Change in blood urea nitrogen (BUN) concentration
Description
The change in serum BUN after intervention compared to baseline.
Time Frame
Change in serum BUN concentration at 24 hours after surgery compared to preoperative baseline BUN concentration
Secondary Outcome Measure Information:
Title
Inflammation
Description
The change in serum concentration of inflammatory mediators after intervention compared to baseline.
Time Frame
Change in serum cytokine concentrations comparing serum concentrations at 24 hours after surgery to serum concentrations immediately (with 1 hour) after surgery
Title
all cause mortality
Description
Death 28 days after surgery and intervention
Time Frame
within 28 days after surgery
Title
duration of ICU stay
Description
ICU length of stay 28 days after surgery and intervention
Time Frame
within 28 days after surgery
Title
duration of hospital stay
Description
Hospital length of stay 28 days after surgery and intervention
Time Frame
within 28 days after surgery
Title
Ventilator-free days
Description
Cumulative days without mechanical ventilation 28 days after surgery and intervention
Time Frame
within 28 days after surgery
Title
Duration of renal replacement therapy
Description
Days of dialysis within the first 28 days after surgery and intervention
Time Frame
within 28 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R Rosengart, MD MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27114521
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.
Results Reference
background
PubMed Identifier
22827924
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.
Results Reference
background
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Light Therapy in Cardiopulmonary Bypass Surgery
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