Blue Light Therapy for Liver Surgery

Not Applicable

Terminated

• Conditions: Inflammation; Liver Injury; Acute Kidney Injury
• Interventions: Other: Blue light

• Registration Number: NCT02915081
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-10
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Study Start: 2017-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blue light	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	for the duration of postoperative inpatient hospital stay up to 28 days
Change in serum cytokine concentrations at 24 hours after surgery	24 hours after surgery	serum will be analyzed for cytokines and inflammatory mediators
Ventilator-free days	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	serum will be analyzed for cytokines and inflammatory mediators

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States