Ignite Creation Date:
2024-05-06 @ 12:42 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03822949
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2019-01-27
Brief Title:
Bright Light Exposure in Critical Ill Patients
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Bright Light Exposure in Critical Ill Patients and Patients Undergoing Cardiac Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery and with a decrease of Troponin I levels after surgery In addition we hypothesize that light therapy leads to Per2 dependent metabolic optimization in the human cardiac tissue Therefore a small piece of human heart tissue from the right atrium will be collected during cardiac cannulation which will be otherwise discarded
2 Critical illness being in the intensive care unit results in circadian malfunction and vessels not working Vessel function is controlled by the bodys circadian clock Intense light boosts the circadian clock and the vessel function in animal studies Vessels not working well in critical ill patients results in a myriad of severe diseases delirium stroke heart attack organ damage etc Thus we will test if intense light can be used to boost the circadian clock and the associated vessel function in critical ill patients
2 Critical illness being in the intensive care unit results in circadian malfunction and vessels not working Vessel function is controlled by the bodys circadian clock Intense light boosts the circadian clock and the vessel function in animal studies Vessels not working well in critical ill patients results in a myriad of severe diseases delirium stroke heart attack organ damage etc Thus we will test if intense light can be used to boost the circadian clock and the associated vessel function in critical ill patients
Detailed Description:
PER2 transcript and protein levels in patients undergoing cardiac surgery following intense light therapy utilizing blood samples buccal swaps and right atrial myocardium In addition we will examine the correlation of PER2 levels and PER2 related metabolism and perform a whole genome microarray screen from the collected tissueblood samples
Patients will be enrolled 10 to 1 days prior to surgery and will either receive an intense bright light box or a placebocontrol device dimnight light box The patient will start using the light box 7 days prior to surgery every morning from 830 to 900 AM The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period
1 Blood buccal swabs will be collected on the day of enrollment 10-1 days prior to surgery between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of lightplacebo therapy
A small piece of the right atrial myocardium which stems from cardiac cannulation and is otherwise discarded will be put in liquid nitrogen in the OR and stored for further analysis
In addition we will draw a blood sample 72 hrs after surgery and determine Troponin I levels
Investigating this patient population will give the necessary evidence if light could also be effective in a perioperative setting to prevent or decrease damage to the myocardium during high risk cardiac surgery In addition it will help us understand if light could be used in general to prevent or treat heart ischemia
2 We will use our light boxes for 30 minutes in ICU care patients on the first morning after admission from 830 to 900 AM Before light therapysunrise and immediately after light therapy a blood sample is drawn These samples will be analyzed for melatonin levels We have demonstrated that effective intense blue intense light therapy significantly suppresses melatonin plasma levels in health human volunteers which is the desired outcome of light therapy We also have shown that light exposure via windows does not achieve such a result Light therapy will be continued for up to 10 days and blood samples are drawn each morning before sunrise and after light therapy In patients that are sedated and have their eyes closed eyes will be opened manually and lubricated before light therapy is initiated The sample size will be n40 10 light treatment 5 days 10 light treatment 10 days and 10 standard room light treatment 5 and 10 days Additional readouts from plasma sample will be triglyceride and ANGPTL4 levels as we have already shown that intense light significantly downregulates triglycerides in healthy volunteers Further we recently discovered ANGPTL4 as major light dependent protein ANGPTL4 is a key regulator of triglycerides and of endothelial function in humans and triglyceride levels are also indicative of endothelial function This approach will allow us to evaluate the effectiveness of our light therapy approach and will further give insight into light elicited endothelial mechanisms in humans
To further study endothelial function we will use the Endo_PAT device Itamar Medical Ltd Franklin MA which has been shown to reliably detect endothelial dysfunction and alterations in critical ill patients This device has been shown to even work when patients who are on vasopressor therapy This device is noninvasive and works like an SpO2 monitor with built in cuff pressure measurement
Finally we will use Actigraphy Actiwatch Phillips to analyze circadian patterns and associated changes following light therapy We already have purchased FDA approved Actigraphy devices and shown that intense light strengthens the circadian rhythms in healthy volunteers Watches will be around the wrist for the duration of the light therapy and are noninvasive
Patients will be enrolled 10 to 1 days prior to surgery and will either receive an intense bright light box or a placebocontrol device dimnight light box The patient will start using the light box 7 days prior to surgery every morning from 830 to 900 AM The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period
1 Blood buccal swabs will be collected on the day of enrollment 10-1 days prior to surgery between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of lightplacebo therapy
A small piece of the right atrial myocardium which stems from cardiac cannulation and is otherwise discarded will be put in liquid nitrogen in the OR and stored for further analysis
In addition we will draw a blood sample 72 hrs after surgery and determine Troponin I levels
Investigating this patient population will give the necessary evidence if light could also be effective in a perioperative setting to prevent or decrease damage to the myocardium during high risk cardiac surgery In addition it will help us understand if light could be used in general to prevent or treat heart ischemia
2 We will use our light boxes for 30 minutes in ICU care patients on the first morning after admission from 830 to 900 AM Before light therapysunrise and immediately after light therapy a blood sample is drawn These samples will be analyzed for melatonin levels We have demonstrated that effective intense blue intense light therapy significantly suppresses melatonin plasma levels in health human volunteers which is the desired outcome of light therapy We also have shown that light exposure via windows does not achieve such a result Light therapy will be continued for up to 10 days and blood samples are drawn each morning before sunrise and after light therapy In patients that are sedated and have their eyes closed eyes will be opened manually and lubricated before light therapy is initiated The sample size will be n40 10 light treatment 5 days 10 light treatment 10 days and 10 standard room light treatment 5 and 10 days Additional readouts from plasma sample will be triglyceride and ANGPTL4 levels as we have already shown that intense light significantly downregulates triglycerides in healthy volunteers Further we recently discovered ANGPTL4 as major light dependent protein ANGPTL4 is a key regulator of triglycerides and of endothelial function in humans and triglyceride levels are also indicative of endothelial function This approach will allow us to evaluate the effectiveness of our light therapy approach and will further give insight into light elicited endothelial mechanisms in humans
To further study endothelial function we will use the Endo_PAT device Itamar Medical Ltd Franklin MA which has been shown to reliably detect endothelial dysfunction and alterations in critical ill patients This device has been shown to even work when patients who are on vasopressor therapy This device is noninvasive and works like an SpO2 monitor with built in cuff pressure measurement
Finally we will use Actigraphy Actiwatch Phillips to analyze circadian patterns and associated changes following light therapy We already have purchased FDA approved Actigraphy devices and shown that intense light strengthens the circadian rhythms in healthy volunteers Watches will be around the wrist for the duration of the light therapy and are noninvasive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL122472 | NIH | None | httpsreporternihgovquickSearchR01HL122472 |