Light Therapy in Cardiopulmonary Bypass Surgery

Sponsor
University of Pittsburgh (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02928887
Collaborator
(none)
0
1
2
21.9
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blue light
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Light Therapy in Cardiopulmonary Bypass Surgery
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Jan 19, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. all cause mortality [within 28 days after surgery]

    Death 28 days after surgery and intervention

  3. duration of ICU stay [within 28 days after surgery]

    ICU length of stay 28 days after surgery and intervention

  4. duration of hospital stay [within 28 days after surgery]

    Hospital length of stay 28 days after surgery and intervention

  5. Ventilator-free days [within 28 days after surgery]

    Cumulative days without mechanical ventilation 28 days after surgery and intervention

  6. Duration of renal replacement therapy [within 28 days after surgery]

    Days of dialysis within the first 28 days after surgery and intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Presbyterian Hospital Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

  • Principal Investigator: Matthew R Rosengart, MD MPH, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Matthew Rosengart, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02928887
Other Study ID Numbers:
  • PRO16090192
First Posted:
Oct 10, 2016
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2022