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Blue Light for Infections
N/A
Recruiting
Led By Matthew R Rosengart, MD MPH
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients greater than or equal to 18 years old and undergoing 1) appendectomy for appendicitis, 2) colon resection for diverticulitis,, and 3) treatment of pneumonia.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comparing time of randomization and at 72 hours after randomization
Awards & highlights
No Placebo-Only Group
Summary
This trial found that blue light exposure was able to modulate the host response to injury and critical illness, potentially improving outcome.
Who is the study for?
This trial is for adults over 18 who are undergoing surgery for appendicitis or diverticulitis, or receiving treatment for pneumonia. It's not suitable for individuals with traumatic brain injury, blindness, or those who have weakened immune systems.
What is being tested?
The study tests the effects of blue light exposure on patients' inflammatory responses after surgeries like appendectomy and colon resection, and during pneumonia treatment. The control group doesn't receive blue light to compare outcomes.
What are the potential side effects?
Since this trial involves exposure to blue light rather than medication, traditional side effects may not apply. However, potential discomforts could include eye strain or headache from the light.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and having surgery for appendicitis, diverticulitis, or being treated for pneumonia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ comparing time of randomization and at 72 hours after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~comparing time of randomization and at 72 hours after randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
All Cohorts: change in serum concentrations of circulating inflammatory mediators in the blood
All groups: change in expression of circadian proteins in circulating immune cells
Pneumonia: change in bronchoalveolar lavage (BAL) bacteria concentration
Secondary study objectives
All Cohorts: change in organ dysfunction
Appendicitis and Diverticulitis: intraabdominal abscess formation
Pneumonia: need for and duration of mechanical ventilation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Pneumonia: Blue LightExperimental Treatment1 Intervention
a 12 hours:12 hours light:dark photoperiod cycle of bright (1700 lux) blue (peak 442 nm) enriched light for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter.
Group II: Necrotizing Soft Tissue Infection: Blue LightExperimental Treatment1 Intervention
a 12 hours:12 hours light:dark photoperiod cycle of bright (1700 lux) blue (peak 442 nm) enriched light for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter.
Group III: Intraabdominal infection: Blue LightExperimental Treatment1 Intervention
a 12 hours:12 hours light:dark photoperiod cycle of bright (1700 lux) blue (peak 442 nm) enriched light for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter.
Group IV: Infected Joint: Blue LightExperimental Treatment1 Intervention
a 12 hours:12 hours light:dark photoperiod cycle of bright (1700 lux) blue (peak 442 nm) enriched light for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter.
Group V: Necrotizing Soft Tissue Infection: Ambient LightActive Control1 Intervention
a 12 hours:12 hours light:dark photoperiod cycle of the standard white fluorescent ambient light of the hospital for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the ambient white lights are turned off.
Group VI: Intraabdominal infection: Ambient LightActive Control1 Intervention
a 12 hours:12 hours light:dark photoperiod cycle of the standard white fluorescent ambient light of the hospital for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the ambient white lights are turned off.
Group VII: Infected Joint: Ambient LightActive Control1 Intervention
a 12 hours:12 hours light:dark photoperiod cycle of the standard white fluorescent ambient light of the hospital for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the ambient white lights are turned off.
Group VIII: Pneumonia: Ambient LightActive Control1 Intervention
a 12 hours:12 hours light:dark photoperiod cycle of the standard white fluorescent ambient light of the hospital for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the ambient white lights are turned off.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,344,114 Total Patients Enrolled
11 Trials studying Pneumonia
78,052 Patients Enrolled for Pneumonia
University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,842 Total Patients Enrolled
5 Trials studying Pneumonia
2,083 Patients Enrolled for Pneumonia
National Institute of General Medical Sciences (NIGMS)NIH
299 Previous Clinical Trials
248,883 Total Patients Enrolled
2 Trials studying Pneumonia
2,052 Patients Enrolled for Pneumonia
Matthew R Rosengart, MD MPHPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
10,192 Total Patients Enrolled