Blue Light Therapy for Liver Surgery

Inflammation Clinical Trial

Official title:

Blue Light Therapy for Liver Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02915081
• Other study ID #: PRO13080427
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Inflammation
• Liver Injury
• Wounds and Injuries

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institutes of Health (NIH), University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline creatinine concentration at 24 hours after surgery	a serum marker of acute kidney injury	preoperatively and 24 hours after surgery
Primary	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	Change in serum cytokine concentrations at 24 hours after surgery	serum will be analyzed for cytokines and inflammatory mediators	24 hours after surgery
Secondary	Ventilator-free days		for the duration of postoperative inpatient hospital stay up to 28 days
Secondary	ICU length of stay		for the duration of postoperative inpatient hospital stay up to 28 days
Secondary	renal replacement therapy		for the duration of postoperative inpatient hospital stay up to 28 days
Secondary	Change in serum cytokine concentrations at 1 hour after surgery	serum will be analyzed for cytokines and inflammatory mediators	1 hours after surgery