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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02915081
Other study ID # PRO13080427
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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