RecruitingNot ApplicableNCT03482245

The Role of Circadian Clock Proteins in Innate and Adaptive Immunity

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

Enrollment

144 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the role of circadian clock proteins — the biological mechanisms that control your body's internal 24-hour rhythms — in how the immune system responds to severe infections. When you have a serious infection requiring hospitalization, your immune response is critical to survival, and researchers believe that circadian clock disruption (such as from disrupted sleep, light exposure, or irregular schedules in hospital) may impair immune function and worsen outcomes. This study collects blood and tissue samples from hospitalized patients with severe infections to compare immune cell function at different times of day, helping researchers understand how biological rhythms influence the body's ability to fight infection. You may be eligible if: - You are between 18 and 65 years old - You are hospitalized for one of the following: surgery for an abdominal infection, surgery for a severe skin/tissue infection (necrotizing fasciitis), surgery for an infected joint, or hospital treatment for pneumonia You may NOT be eligible if: - You have a traumatic brain injury - You are blind - You have a condition or are taking medication that suppresses your immune system - You have had an infection requiring treatment in the past 30 days - You have been diagnosed with COVID-19 (SARS-CoV-2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlue Light

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.


Locations(1)

Barnes Jewish Hospital

St Louis, Missouri, United States

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NCT03482245


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