Blue Light Therapy for Liver Surgery
Primary Purpose
Acute Kidney Injury, Liver Injury, Inflammation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blue light
Sponsored by
About this trial
This is an interventional basic science trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- age greater than 17 years
- undergoing right or left hepatic lobectomy
Exclusion Criteria:
- presence of acute traumatic brain injury
- blindness
- immunosuppression or immunocompromised condition
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Blue light
Ambient light
Arm Description
Subjects will be exposed to 24 hours of bright (1700 lux) blue (peak 442 nm) spectrum light the day prior to operative intervention and for the 24 hours after the operative intervention.
Subjects will be exposed preoperatively to the lighting conditions of their living environment and postoperatively to the standard, white fluorescent lighting environment of the hospital.
Outcomes
Primary Outcome Measures
Change from baseline creatinine concentration at 24 hours after surgery
a serum marker of acute kidney injury
Change from baseline alanine aminotransferase (ALT) concentration at 24 hours after surgery
a serum marker of acute liver injury
Secondary Outcome Measures
Change in serum cytokine concentrations at 24 hours after surgery
serum will be analyzed for cytokines and inflammatory mediators
Ventilator-free days
ICU length of stay
renal replacement therapy
Change in serum cytokine concentrations at 1 hour after surgery
serum will be analyzed for cytokines and inflammatory mediators
Full Information
NCT ID
NCT02915081
First Posted
September 10, 2016
Last Updated
April 3, 2019
Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), University of Pittsburgh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02915081
Brief Title
Blue Light Therapy for Liver Surgery
Official Title
Blue Light Therapy for Liver Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
low anticipated recruitment
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), University of Pittsburgh Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators hypothesize that subjects undergoing liver resection and who are exposed preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury, specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent light.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Liver Injury, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blue light
Arm Type
Experimental
Arm Description
Subjects will be exposed to 24 hours of bright (1700 lux) blue (peak 442 nm) spectrum light the day prior to operative intervention and for the 24 hours after the operative intervention.
Arm Title
Ambient light
Arm Type
No Intervention
Arm Description
Subjects will be exposed preoperatively to the lighting conditions of their living environment and postoperatively to the standard, white fluorescent lighting environment of the hospital.
Intervention Type
Other
Intervention Name(s)
Blue light
Intervention Description
Illumination: High illumination lighting will be instituted with a Day*Light Classic Light (Uplift Technologies, Dartmouth, NS)
Blue wavelength: Each subject will be fitted with blue filtered goggles (Lee Filters, Burbank, CA). These goggles ensure the transmission of a bright (1700 lux) blue (peak 442 nm) spectrum light when the subject is within 12 inches.
Photoperiod: A 24-hour photoperiod will be used that commences at 0800 the morning prior to surgery and continues for 24 hours. To account for potential variability in the exposure of interest, each subject will complete a diary to catalogue duration and distance of light exposure. Postoperatively the same photoperiod will be instituted and continued for one 24 hour period.
Primary Outcome Measure Information:
Title
Change from baseline creatinine concentration at 24 hours after surgery
Description
a serum marker of acute kidney injury
Time Frame
preoperatively and 24 hours after surgery
Title
Change from baseline alanine aminotransferase (ALT) concentration at 24 hours after surgery
Description
a serum marker of acute liver injury
Time Frame
preoperatively and 24 hours after surgery
Secondary Outcome Measure Information:
Title
Change in serum cytokine concentrations at 24 hours after surgery
Description
serum will be analyzed for cytokines and inflammatory mediators
Time Frame
24 hours after surgery
Title
Ventilator-free days
Time Frame
for the duration of postoperative inpatient hospital stay up to 28 days
Title
ICU length of stay
Time Frame
for the duration of postoperative inpatient hospital stay up to 28 days
Title
renal replacement therapy
Time Frame
for the duration of postoperative inpatient hospital stay up to 28 days
Title
Change in serum cytokine concentrations at 1 hour after surgery
Description
serum will be analyzed for cytokines and inflammatory mediators
Time Frame
1 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age greater than 17 years
undergoing right or left hepatic lobectomy
Exclusion Criteria:
presence of acute traumatic brain injury
blindness
immunosuppression or immunocompromised condition
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
This trial is a small pilot trial.
Learn more about this trial
Blue Light Therapy for Liver Surgery
We'll reach out to this number within 24 hrs