<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822949</url>
  </required_header>
  <id_info>
    <org_study_id>18-0904</org_study_id>
    <secondary_id>R01HL122472</secondary_id>
    <nct_id>NCT03822949</nct_id>
  </id_info>
  <brief_title>Bright Light Exposure in Critical Ill Patients</brief_title>
  <official_title>Bright Light Exposure in Critical Ill Patients and Patients Undergoing Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Elucidate the influence of intense light therapy pretreatment in patients undergoing&#xD;
           cardiac surgery. We hypothesize that intense light exposure is associated with the&#xD;
           peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery&#xD;
           and with a decrease of Troponin I levels after surgery. In addition, we hypothesize that&#xD;
           light therapy leads to Per2 dependent metabolic optimization in the human cardiac&#xD;
           tissue. Therefore, a small piece of human heart tissue from the right atrium will be&#xD;
           collected during cardiac cannulation, which will be otherwise discarded.&#xD;
&#xD;
        2. Critical illness (being in the intensive care unit) results in circadian malfunction and&#xD;
           vessels not working. Vessel function is controlled by the body's circadian clock.&#xD;
           Intense light boosts the circadian clock and the vessel function in animal studies.&#xD;
           Vessels not working well in critical ill patients results in a myriad of severe diseases&#xD;
           (delirium, stroke, heart attack, organ damage etc). Thus we will test if intense light&#xD;
           can be used to boost the circadian clock and the associated vessel function in critical&#xD;
           ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PER2 transcript and protein levels in patients undergoing cardiac surgery following intense&#xD;
      light therapy utilizing blood samples, buccal swaps and right atrial myocardium. In addition,&#xD;
      we will examine the correlation of PER2 levels and PER2 related metabolism and perform a&#xD;
      whole genome microarray screen from the collected tissue/blood samples.&#xD;
&#xD;
      Patients will be enrolled 10 to 1 days prior to surgery and will either receive an intense&#xD;
      (bright light) box or a placebo/control device (dim/night light box). The patient will start&#xD;
      using the light box 7 days prior to surgery every morning from 8.30 to 9.00 AM. The patient&#xD;
      will need to keep the box as close as possible to their eyes and not walk away during the&#xD;
      treatment period.&#xD;
&#xD;
        1. Blood /buccal swabs will be collected on the day of enrollment (10-1 days prior to&#xD;
           surgery) between 7 and 10 AM without any light therapy and on the day of surgery between&#xD;
           7 and 10 AM before anesthesia induction after one week of light/placebo therapy.&#xD;
&#xD;
           A small piece of the right atrial myocardium (which stems from cardiac cannulation and&#xD;
           is otherwise discarded) will be put in liquid nitrogen in the OR and stored for further&#xD;
           analysis.&#xD;
&#xD;
           In addition, we will draw a blood sample 72 hrs. after surgery and determine Troponin I&#xD;
           levels.&#xD;
&#xD;
           Investigating this patient population will give the necessary evidence if light could&#xD;
           also be effective in a perioperative setting to prevent or decrease damage to the&#xD;
           myocardium during high risk cardiac surgery. In addition, it will help us understand if&#xD;
           light could be used in general to prevent or treat heart ischemia.&#xD;
&#xD;
        2. We will use our light boxes for 30 minutes in ICU care patients on the first morning&#xD;
           after admission from 8.30 to 9.00 AM. Before light therapy/sunrise and immediately after&#xD;
           light therapy, a blood sample is drawn. These samples will be analyzed for melatonin&#xD;
           levels. We have demonstrated that effective intense blue intense light therapy&#xD;
           significantly suppresses melatonin plasma levels in health human volunteers which is the&#xD;
           desired outcome of light therapy. We also have shown that light exposure via windows&#xD;
           does not achieve such a result. Light therapy will be continued for up to 10 days, and&#xD;
           blood samples are drawn each morning before sunrise and after light therapy. In patients&#xD;
           that are sedated and have their eyes closed, eyes will be opened manually and lubricated&#xD;
           before light therapy is initiated. The sample size will be n=40 (10 light treatment 5&#xD;
           days, 10 light treatment 10 days and 10 standard room light treatment 5 and 10 days).&#xD;
           Additional readouts from plasma sample will be triglyceride and ANGPTL4 levels as we&#xD;
           have already shown that intense light significantly downregulates triglycerides in&#xD;
           healthy volunteers. Further, we recently discovered ANGPTL4 as major light dependent&#xD;
           protein. ANGPTL4 is a key regulator of triglycerides and of endothelial function in&#xD;
           humans and triglyceride levels are also indicative of endothelial function. This&#xD;
           approach will allow us to evaluate the effectiveness of our light therapy approach and&#xD;
           will further give insight into light elicited endothelial mechanisms in humans.&#xD;
&#xD;
      To further study endothelial function, we will use the Endo_PAT device (Itamar Medical Ltd,&#xD;
      Franklin, MA) which has been shown to reliably detect endothelial dysfunction and alterations&#xD;
      in critical ill patients. This device has been shown to even work when patients who are on&#xD;
      vasopressor therapy. This device is noninvasive and works like an SpO2 monitor with built in&#xD;
      cuff pressure measurement.&#xD;
&#xD;
      Finally, we will use Actigraphy (Actiwatch, Phillips) to analyze circadian patterns and&#xD;
      associated changes following light therapy. We already have purchased FDA approved Actigraphy&#xD;
      devices and shown that intense light strengthens the circadian rhythms in healthy volunteers.&#xD;
      Watches will be around the wrist for the duration of the light therapy and are noninvasive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2019</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Period 2 (Per2) protein levels</measure>
    <time_frame>1-10 days</time_frame>
    <description>Measure of Per2 protein levels related to daylight exposure vs. room light exposure.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Myocardial Ischemia</condition>
  <condition>Critical Illness</condition>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>Experimental: Exposed to Day light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive an intense (bright light, Square One Wake Up Light NatureBright 10,000 LUX) box. The patient will start using the light box prior to surgery every morning from 8.30 to 9.00 AM. Blood /buccal swabs will be collected on the day of enrollment (10 to 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 light therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Comparator: Exposed to Room light</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive a placebo/control device (dim/night light box). The patient will start using the light box 7 days prior to surgery every morning from 8.30 to 9.00 AM. Blood /buccal swabs will be collected on the day of enrollment (10 to 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 placebo therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: ICU Exposed to Day light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes intense light each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device. The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period. This will be facilities by a study nurse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Comparator: ICU Exposed to Room light</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes using a placebo/control device (dim/night light box) each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Day Light</intervention_name>
    <description>Patients are exposed to daylight for up to 10 days prior to surgery</description>
    <arm_group_label>Experimental: Exposed to Day light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo light</intervention_name>
    <description>Patients are exposed to placebo light for up to 10 days prior to surgery</description>
    <arm_group_label>Sham Comparator: Exposed to Room light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ICU Intense Light</intervention_name>
    <description>ICU Patients are exposed to daylight for up to 10 days after surgery</description>
    <arm_group_label>Experimental: ICU Exposed to Day light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ICU Placebo light</intervention_name>
    <description>ICU Patients are exposed to placebo light for up to 10 days after surgery</description>
    <arm_group_label>Sham Comparator: ICU Exposed to Room light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing primary sternotomy cardiac surgery&#xD;
&#xD;
          -  Subjects in the range of 18 - 90 years old .&#xD;
&#xD;
          -  Patient need to be in sinus rhythm at the time of surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients &lt;18 or &gt;90 years old&#xD;
&#xD;
          -  participation in other clinical trials within the previous 30 days&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  neurological conditions that could impair weaning from ventilator support&#xD;
&#xD;
          -  significant CNS disorders or comorbid irreversible conditions with a six-month&#xD;
             mortality rate more than 50 percent&#xD;
&#xD;
          -  prisoners, or subjects with altered capabilities to make decision will be enrolled&#xD;
&#xD;
          -  medical history of type 2 diabetes&#xD;
&#xD;
          -  patients with atrial fibrillation or use of class III anti-arhythmic drug&#xD;
&#xD;
          -  patients with a left ventricle ejection fraction &lt; 40%&#xD;
&#xD;
          -  patient in emergency condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Eckle, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tobias Eckle, MD, PhD</last_name>
    <phone>7209495646</phone>
    <email>tobias.eckle@cuanschutz.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nick Naughton, BS</last_name>
    <phone>303-724-0833</phone>
    <email>NICK.NAUGHTON@CUANSCHUTZ.EDU</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Colorado Denver | Anschutz Medical Campus</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220-3706</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nick M Naughton, BS</last_name>
      <phone>303-724-0833</phone>
      <email>NICK.NAUGHTON@CUANSCHUTZ.EDU</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://ucdenver.edu/academics/colleges/medicalschool/departments/Anesthesiology/Research/labs/Dr.%20Eckle%20lab/Pages/default.aspx</url>
    <description>Research homepage</description>
  </link>
  <reference>
    <citation>Bartman CM, Oyama Y, Eckle T. Daytime variations in perioperative myocardial injury. Lancet. 2018 May 26;391(10135):2104. doi: 10.1016/S0140-6736(18)30797-9. Epub 2018 May 24. No abstract available.</citation>
    <PMID>29856340</PMID>
  </reference>
  <reference>
    <citation>Oyama Y, Bartman CM, Gile J, Eckle T. Circadian MicroRNAs in Cardioprotection. Curr Pharm Des. 2017;23(25):3723-3730. doi: 10.2174/1381612823666170707165319.</citation>
    <PMID>28699517</PMID>
  </reference>
  <reference>
    <citation>Bonney S, Hughes K, Harter PN, Mittelbronn M, Walker L, Eckle T. Cardiac period 2 in myocardial ischemia: clinical implications of a light dependent protein. Int J Biochem Cell Biol. 2013 Mar;45(3):667-71. doi: 10.1016/j.biocel.2012.12.022. Epub 2013 Jan 3.</citation>
    <PMID>23291353</PMID>
  </reference>
  <results_reference>
    <citation>Oyama Y, Bartman CM, Gile J, Sehrt D, Eckle T. The Circadian PER2 Enhancer Nobiletin Reverses the Deleterious Effects of Midazolam in Myocardial Ischemia and Reperfusion Injury. Curr Pharm Des. 2018;24(28):3376-3383. doi: 10.2174/1381612824666180924102530.</citation>
    <PMID>30246635</PMID>
  </results_reference>
  <results_reference>
    <citation>Bartman CM, Oyama Y, Brodsky K, Khailova L, Walker L, Koeppen M, Eckle T. Intense light-elicited upregulation of miR-21 facilitates glycolysis and cardioprotection through Per2-dependent mechanisms. PLoS One. 2017 Apr 27;12(4):e0176243. doi: 10.1371/journal.pone.0176243. eCollection 2017.</citation>
    <PMID>28448534</PMID>
  </results_reference>
  <results_reference>
    <citation>Bonney S, Kominsky D, Brodsky K, Eltzschig H, Walker L, Eckle T. Cardiac Per2 functions as novel link between fatty acid metabolism and myocardial inflammation during ischemia and reperfusion injury of the heart. PLoS One. 2013 Aug 20;8(8):e71493. doi: 10.1371/journal.pone.0071493. eCollection 2013.</citation>
    <PMID>23977055</PMID>
  </results_reference>
  <results_reference>
    <citation>Eckle T, Hartmann K, Bonney S, Reithel S, Mittelbronn M, Walker LA, Lowes BD, Han J, Borchers CH, Buttrick PM, Kominsky DJ, Colgan SP, Eltzschig HK. Adora2b-elicited Per2 stabilization promotes a HIF-dependent metabolic switch crucial for myocardial adaptation to ischemia. Nat Med. 2012 Apr 15;18(5):774-82. doi: 10.1038/nm.2728.</citation>
    <PMID>22504483</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822949
org study id: 18-0904
secondary id: R01HL122472
nct id: NCT03822949
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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 body's 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.
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 tissue/blood samples.

      Patients will be enrolled 10 to 1 days prior to surgery and will either receive an intense
      (bright light) box or a placebo/control device (dim/night light box). The patient will start
      using the light box 7 days prior to surgery every morning from 8.30 to 9.00 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 light/placebo 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 8.30 to 9.00 AM. Before light therapy/sunrise 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 n=40 (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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change of Period 2 (Per2) protein levels
time frame: 1-10 days
description: Measure of Per2 protein levels related to daylight exposure vs. room light exposure.
arm group label: Experimental: Exposed to Day light
arm group type: Experimental
description: Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive an intense (bright light, Square One Wake Up Light NatureBright 10,000 LUX) box. The patient will start using the light box prior to surgery every morning from 8.30 to 9.00 AM. Blood /buccal swabs will be collected on the day of enrollment (10 to 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 light therapy.
arm group label: Sham Comparator: Exposed to Room light
arm group type: Placebo Comparator
description: Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive a placebo/control device (dim/night light box). The patient will start using the light box 7 days prior to surgery every morning from 8.30 to 9.00 AM. Blood /buccal swabs will be collected on the day of enrollment (10 to 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 placebo therapy.
arm group label: Experimental: ICU Exposed to Day light
arm group type: Experimental
description: Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes intense light each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device. The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period. This will be facilities by a study nurse.
arm group label: Sham Comparator: ICU Exposed to Room light
arm group type: Placebo Comparator
description: Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes using a placebo/control device (dim/night light box) each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device.
intervention type: Device
intervention name: Day Light
description: Patients are exposed to daylight for up to 10 days prior to surgery
arm group label: Experimental: Exposed to Day light
intervention type: Device
intervention name: Placebo light
description: Patients are exposed to placebo light for up to 10 days prior to surgery
arm group label: Sham Comparator: Exposed to Room light
intervention type: Device
intervention name: ICU Intense Light
description: ICU Patients are exposed to daylight for up to 10 days after surgery
arm group label: Experimental: ICU Exposed to Day light
intervention type: Device
intervention name: ICU Placebo light
description: ICU Patients are exposed to placebo light for up to 10 days after surgery
arm group label: Sham Comparator: ICU Exposed to Room light
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Tobias Eckle, MD, PhD
role: Principal Investigator
affiliation: UC Denver
last name: Tobias Eckle, MD, PhD
phone: 7209495646
email: tobias.eckle@cuanschutz.edu
last name: Nick Naughton, BS
phone: 303-724-0833
email: NICK.NAUGHTON@CUANSCHUTZ.EDU
facility: 
status: Recruiting
contact: 
country: United States
url: http://ucdenver.edu/academics/colleges/medicalschool/departments/Anesthesiology/Research/labs/Dr.%20Eckle%20lab/Pages/default.aspx
description: Research homepage
citation: Bartman CM, Oyama Y, Eckle T. Daytime variations in perioperative myocardial injury. Lancet. 2018 May 26;391(10135):2104. doi: 10.1016/S0140-6736(18)30797-9. Epub 2018 May 24. No abstract available.
PMID: 29856340
citation: Oyama Y, Bartman CM, Gile J, Eckle T. Circadian MicroRNAs in Cardioprotection. Curr Pharm Des. 2017;23(25):3723-3730. doi: 10.2174/1381612823666170707165319.
PMID: 28699517
citation: Bonney S, Hughes K, Harter PN, Mittelbronn M, Walker L, Eckle T. Cardiac period 2 in myocardial ischemia: clinical implications of a light dependent protein. Int J Biochem Cell Biol. 2013 Mar;45(3):667-71. doi: 10.1016/j.biocel.2012.12.022. Epub 2013 Jan 3.
PMID: 23291353
citation: Oyama Y, Bartman CM, Gile J, Sehrt D, Eckle T. The Circadian PER2 Enhancer Nobiletin Reverses the Deleterious Effects of Midazolam in Myocardial Ischemia and Reperfusion Injury. Curr Pharm Des. 2018;24(28):3376-3383. doi: 10.2174/1381612824666180924102530.
PMID: 30246635
citation: Bartman CM, Oyama Y, Brodsky K, Khailova L, Walker L, Koeppen M, Eckle T. Intense light-elicited upregulation of miR-21 facilitates glycolysis and cardioprotection through Per2-dependent mechanisms. PLoS One. 2017 Apr 27;12(4):e0176243. doi: 10.1371/journal.pone.0176243. eCollection 2017.
PMID: 28448534
citation: Bonney S, Kominsky D, Brodsky K, Eltzschig H, Walker L, Eckle T. Cardiac Per2 functions as novel link between fatty acid metabolism and myocardial inflammation during ischemia and reperfusion injury of the heart. PLoS One. 2013 Aug 20;8(8):e71493. doi: 10.1371/journal.pone.0071493. eCollection 2013.
PMID: 23977055
citation: Eckle T, Hartmann K, Bonney S, Reithel S, Mittelbronn M, Walker LA, Lowes BD, Han J, Borchers CH, Buttrick PM, Kominsky DJ, Colgan SP, Eltzschig HK. Adora2b-elicited Per2 stabilization promotes a HIF-dependent metabolic switch crucial for myocardial adaptation to ischemia. Nat Med. 2012 Apr 15;18(5):774-82. doi: 10.1038/nm.2728.
PMID: 22504483
responsible party type: Sponsor
mesh term: Myocardial Ischemia
mesh term: Ischemia
mesh term: Critical Illness
sharing ipd: No