Blue Light Therapy for Liver Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Inflammation; Acute Kidney Injury; Liver Injury
• Intervention / Treatment: Other: Blue light

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue light; 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.	Other: Blue light; 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.
No Intervention: Ambient light; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline creatinine concentration at 24 hours after surgery	a serum marker of acute kidney injury	preoperatively and 24 hours after surgery
Change from baseline alanine aminotransferase (ALT) concentration at 24 hours after surgery	a serum marker of acute liver injury	preoperatively and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum cytokine concentrations at 24 hours after surgery	serum will be analyzed for cytokines and inflammatory mediators	24 hours after surgery
Ventilator-free days		for the duration of postoperative inpatient hospital stay up to 28 days
ICU length of stay		for the duration of postoperative inpatient hospital stay up to 28 days
renal replacement therapy		for the duration of postoperative inpatient hospital stay up to 28 days
Change in serum cytokine concentrations at 1 hour after surgery	serum will be analyzed for cytokines and inflammatory mediators	1 hours after surgery

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institutes of Health (NIH); University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: September 10, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Inflammation; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: PRO13080427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This trial is a small pilot trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No