What this study is
Our data suggest that modulating the characteristics of light carries the potential to modify the host response to injury and critical illness and thus, improve outcome. The ability to modify the host response to the stress of major operations and sepsis carries immense potential to improve patient care.
The primary purpose of this study is to determine if exposure to bright blue (442nm) enriched light, by comparison to ambient white fluorescent light, reduces the inflammatory response or organ dysfunction in patients undergoing 1) medical treatment for pneumonia, 2) a 2-stage arthroplasty for surgical management of a septic joint, 3) surgery for a necrotizing soft tissue infection (NSTI), and 4) surgery for an intraabdominal infection (e.g., diverticulitis).
We will expose participants to one of two (2) lighting conditions: 1) high illuminance (~1700 lux,), blue (442nm) spectrum enriched light and 2) ambient white fluorescent light that provides the standard environmental lighting (~300-400 lux, no predominant spectrum) of the hospital.
Both cohorts will be exposed to a 12 hours:12 hours light:dark cycle photoperiod. Those subjects assigned to blue light will be asked to shine this small portable blue enriched light on themselves from 0800 to 2000 for 3 days. At the transition from light to dark, the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter. Thus, the total period of intervention is 72 hours.
The outcome of interest is change in the inflammatory response after surgery for appendicitis or diverticulitis as measured by the following parameters: white blood cell count, heart rate, the development of abdominal abscess, serum cytokine concentrations.
The outcome of interest is change in the inflammatory response during pneumonia as measured by the following parameters: white blood cell count, heart rate, and serum cytokine concentrations.
What's being tested
- Blue Light
Intervention · OTHER
Subjects that are to be exposed to blue light will be provided by the research personnel with a Day-Light Classic 10,000 lumen SAD light, a device that has been used in many of the previously listed published studies (Epilepsy Behav. 2012 Jul;24(3):359-64. doi: 10.1016/j.yebeh.2012.04.123. Epub 2012 May 30.) The light is small (4 X 16 X 21 inches) and weights less than a pound. It is UV filtered and glare free. There is a single "On/Off" switch. It will be attached to a rolling stand. This light is fitted with a blue spectrum filter (peak 442 nm) such that it produces 1700 Lux of blue spectrum lighting when positioned at a distance of 12 inches from the subject. Those subjects assigned to blue light will be asked to shine this small portable blue enriched light on themselves from 0800 to 2000 for 3 days.
Study details
- Official title
- Light Therapy in Patients Undergoing an Operation for a Septic Joint, Necrotizing Soft Tissue Infection, Intraabdominal Sepsis, or Medical Treatment of Pneumonia
- Sponsor
- Washington University School of Medicine
- Conditions
- Pneumonia · Necrotizing Soft Tissue Infection · Intraabdominal Infections · Infection Joint
- Enrolling
- 144 people
- Starts
- 2024-10-29
- Est. completion
- 2026-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Greater than or equal to 18 years of age and less than or equal to 65 years of age
- One of the following diagnoses requiring inpatient hospital care; an operation for intraabdominal infection; an operation for necrotizing soft tissue infection; an operation for an infected joint; medical treatment of pneumonia.
You can't join if
- Traumatic brain injury
- Blindness
- Immunocompromised or immunosuppressed state
- Infection requiring treatment in preceding 30 days
- Blindness
- SARS-CoV-2
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openBarnes Jewish Hospital
St Louis, Missouri, United States
- Matthew R Rosengart, MD MPH · Contact314-362-5298matthew.r@wustl.edu
- Xianghong Zhang, PhD · Contact412-215-6134xianghong@wustl.edu
Recruiting
Study team
Sponsor
Washington University School of Medicine
Study ID STUDY19030376
Principal investigator
Matthew R Rosengart, MD MPH
Washington University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.