Inflammation Clinical Trial
Official title:
Blue Light Therapy for Liver Surgery
Verified date | April 2019 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institutes of Health (NIH), University of Pittsburgh Medical Center |
United States,
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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