RECRUITING

The Role of Circadian Clock Proteins in Innate and Adaptive Immunity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Light Therapy in Patients Undergoing an Operation for a Septic Joint, Necrotizing Soft Tissue Infection, Intraabdominal Sepsis, or Medical Treatment of Pneumonia

Quick Facts

Study Start:2024-07-17
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03482245

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * greater than or equal to 18 years of age and less than or equal to 65 years of age
  2. * one of the following diagnoses requiring inpatient hospital care
  3. 1. an operation for intraabdominal infection
  4. 2. an operation for necrotizing soft tissue infection
  5. 3. an operation for an infected joint
  6. 4. medical treatment of pneumonia.
  1. * traumatic brain injury
  2. * blindness
  3. * immunocompromised or immunosuppressed state
  4. * infection requiring treatment in preceding 30 days
  5. * blindness
  6. * SARS-CoV-2

Contacts and Locations

Study Contact

Matthew R Rosengart, MD MPH
CONTACT
314-362-5298
matthew.r@wustl.edu
Xianghong Zhang, PhD
CONTACT
412-215-6134
xianghong@wustl.edu

Principal Investigator

Matthew R Rosengart, MD MPH
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Barnes Jewish Hospital
Saint Louis, Missouri, 63108
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Matthew R Rosengart, MD MPH, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Registration Dates

Study Start Date2024-07-17
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-07-17
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • pneumonia
  • soft tissue infection
  • intraabdominal infections
  • circadian rhythms
  • blue light
  • sepsis

Additional Relevant MeSH Terms

  • Pneumonia
  • Necrotizing Soft Tissue Infection
  • Intraabdominal Infections
  • Infection Joint