Light Therapy in Cardiopulmonary Bypass Surgery

January 19, 2022 updated by: Matthew Rosengart, University of Pittsburgh
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in serum creatinine concentration at 24 hours after surgery compared to preoperative baseline creatinine concentration
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.
Change in serum BUN concentration at 24 hours after surgery compared to preoperative baseline BUN concentration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in serum cytokine concentrations comparing serum concentrations at 24 hours after surgery to serum concentrations immediately (with 1 hour) after surgery
all cause mortality
Time Frame: within 28 days after surgery
Death 28 days after surgery and intervention
within 28 days after surgery
duration of ICU stay
Time Frame: within 28 days after surgery
ICU length of stay 28 days after surgery and intervention
within 28 days after surgery
duration of hospital stay
Time Frame: within 28 days after surgery
Hospital length of stay 28 days after surgery and intervention
within 28 days after surgery
Ventilator-free days
Time Frame: within 28 days after surgery
Cumulative days without mechanical ventilation 28 days after surgery and intervention
within 28 days after surgery
Duration of renal replacement therapy
Time Frame: within 28 days after surgery
Days of dialysis within the first 28 days after surgery and intervention
within 28 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

January 19, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO16090192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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