Blue Light Therapy for Liver Surgery

NCT02915081 | Terminated DMC

• 1 other identifier: PRO13080427
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Liver Injury; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in serum cytokine concentrations at 24 hours after surgery

  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

  1 hours after surgery

Study Arms (2)

Blue light

EXPERIMENTAL

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

Ambient light

NO 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.

Interventions

Blue light OTHER

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.

Blue light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 17 years
• undergoing right or left hepatic lobectomy

You may not qualify if:

• presence of acute traumatic brain injury
• blindness
• immunosuppression or immunocompromised condition

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Inflammation

Interventions

Blue Light

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2016
• First Posted: September 26, 2016
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

US (1)