The Role of Circadian Clock Proteins in Innate and Adaptive Immunity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWashington University School of Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
traumatic brain injury
blindness
immunocompromised or immunosuppressed state
infection requiring treatment in preceding 30 days
Trial design
Design model
Parallel
Treatments tested in this trial
Blue Light
Other interventionSubjects 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.
Treatment groups
144 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Pneumonia: Blue LightExperimental treatment 1 intervention
Group B: Intraabdominal infection: Blue LightExperimental treatment 1 intervention
Group C: Necrotizing Soft Tissue Infection: Blue LightExperimental treatment 1 intervention
Group D: Pneumonia: Ambient LightNo intervention 0 interventions
Group E: Intraabdominal infection: Ambient LightNo intervention 0 interventions
Group F: Necrotizing Soft Tissue Infection: Ambient LightNo intervention 0 interventions
Group G: Infected Joint: Blue LightExperimental treatment 1 intervention
Group H: Infected Joint: Ambient LightNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pneumonia: change in bronchoalveolar lavage (BAL) bacteria concentration
quantification of the change in bacterial colony forming units (CFU) in BAL fluid
Time frame
comparing time of randomization and at 72 hours after randomization2
All groups: change in expression of circadian proteins in circulating immune cells
quantification of the change in blood white blood cell counts
Time frame
comparing time of randomization and at 72 hours after randomization3
All Cohorts: change in serum concentrations of circulating inflammatory mediators in the blood
quantification of change in serum cytokine concentrations
Time frame
comparing time of randomization and at 72 hours after randomizationSecondary outcomes
1
Pneumonia: need for and duration of mechanical ventilation
quantification of days on the ventilator
Time frame
comparing time of randomization to 28 days2
All Cohorts: change in organ dysfunction
quantification of change in organ dysfunction using the Sequential Organ Failure Assessment scale
Time frame
comparing time of randomization and at 72 hours after randomization3
Appendicitis and Diverticulitis: intraabdominal abscess formation
rate of development of intraabdominal abscess as measured by #subjects/total subjects
Time frame
from time of randomization to 28-days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov