Inflammation Clinical Trial
Official title:
Light Therapy in Cardiopulmonary Bypass Surgery
Verified date | January 2022 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to determine whether or not exposure to blue spectrum light reduces acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary bypass. Subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to either bright (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light for a 24 hour photoperiod the day prior to surgery and for a 24 hour photoperiod in the immediate postoperative period.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2022 |
Est. primary completion date | January 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age greater than or equal to 18 years - undergoing cardiopulmonary bypass surgery Exclusion Criteria: - Blindness - Immunocompromised or immunosuppressed state - Anticipated survival < 24 hours |
Country | Name | City | State |
---|---|---|---|
United States | Presbyterian Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Castro RA, Angus DC, Hong SY, Lee C, Weissfeld LA, Clermont G, Rosengart MR. Light and the outcome of the critically ill: an observational cohort study. Crit Care. 2012 Jul 24;16(4):R132. doi: 10.1186/cc11437. — View Citation
Yuan D, Collage RD, Huang H, Zhang X, Kautza BC, Lewis AJ, Zuckerbraun BS, Tsung A, Angus DC, Rosengart MR. Blue light reduces organ injury from ischemia and reperfusion. Proc Natl Acad Sci U S A. 2016 May 10;113(19):5239-44. doi: 10.1073/pnas.1515296113. Epub 2016 Apr 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in creatinine concentration | The change in serum creatinine after intervention compared to baseline. | Change in serum creatinine concentration at 24 hours after surgery compared to preoperative baseline creatinine concentration | |
Primary | Change in blood urea nitrogen (BUN) concentration | The change in serum BUN after intervention compared to baseline. | Change in serum BUN concentration at 24 hours after surgery compared to preoperative baseline BUN concentration | |
Secondary | Inflammation | The change in serum concentration of inflammatory mediators after intervention compared to baseline. | Change in serum cytokine concentrations comparing serum concentrations at 24 hours after surgery to serum concentrations immediately (with 1 hour) after surgery | |
Secondary | all cause mortality | Death 28 days after surgery and intervention | within 28 days after surgery | |
Secondary | duration of ICU stay | ICU length of stay 28 days after surgery and intervention | within 28 days after surgery | |
Secondary | duration of hospital stay | Hospital length of stay 28 days after surgery and intervention | within 28 days after surgery | |
Secondary | Ventilator-free days | Cumulative days without mechanical ventilation 28 days after surgery and intervention | within 28 days after surgery | |
Secondary | Duration of renal replacement therapy | Days of dialysis within the first 28 days after surgery and intervention | within 28 days after surgery |
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