<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/NCT03251599</url>
  </required_header>
  <id_info>
    <org_study_id>2017/5</org_study_id>
    <nct_id>NCT03251599</nct_id>
  </id_info>
  <brief_title>The Effect of Nitroglycerin Infusion Rate on Cerebral Rewarming During Hypothermic Coronary Artery Bypass Grafting</brief_title>
  <acronym>nitrotherm</acronym>
  <official_title>The Effect of Two Different Rates of Nitroglycerin Infusion on Cerebral Rewarming During Rewarming Period of Hypothermic Cardiopulmonary Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rize Üniversitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rize Üniversitesi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glyceryl trinitrate is used in coronary artery bypass grafting surgery. This surgery&#xD;
      frequently employs hypothermic cardiopulmonary bypass, where the whole body is cooled down to&#xD;
      28-32 °C to arrest the heart, and protect the organs from ischemic insult. When the cardiac&#xD;
      repair or grafting is done, the body is warmed to 37 °C. During this &quot;rewarming period&quot;, the&#xD;
      heart has to beat against the vessels, all of which are constricted due to hypothermia.&#xD;
&#xD;
      To overcome this constriction of the vessels, and decrease the workload of the heart,&#xD;
      glyceryl trinitrate is infused. This drug causes significant dilatation in arteries and&#xD;
      veins, which allows the heart to pump the blood with less force. The dilatation of the&#xD;
      vessels also allows the body to rewarm more easily.&#xD;
&#xD;
      The investigators' concern is whether increased infusion rates of glyceryl trinitrate may&#xD;
      cause uncontrolled rewarming of the brain or not. The investigators will measure the&#xD;
      temperature of the brain using a temperature probe located in the nasal cavity. The&#xD;
      temperature will be recorded at each minute during the the rewarming period. Results of two&#xD;
      commonly used infusion rates of glyceryl trinitrate will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothermia had demonstrated potential benefits in myocardial infarction, organ&#xD;
      transplantation, and cardiopulmonary bypass. The brain uses 2/3 of the oxygen it receives to&#xD;
      support cerebral electrophysiological function, while the rest is used for maintenance of&#xD;
      cellular integrity. Anesthetic drugs alter only the first portion, while temperature is the&#xD;
      only agent known to affect both portions (the cerebral consumption of oxygen decreases 6-7 %&#xD;
      per degree centigrade reduction in temperature).&#xD;
&#xD;
      Although hypothermia is effectively used to protect the brain and myocardium from ischemia,&#xD;
      studies report that rapid rewarming is correlated with brain injury. Therefore it is common&#xD;
      practice to monitor the nasopharyngeal temperature and to keep the gradient between&#xD;
      heat-exchanger and nasopharynx during rewarming at 2-3 °C.&#xD;
&#xD;
      This study's main concern is that the infusion rate of glyceryl trinitrate may affect the&#xD;
      rewarming rate of the body and the brain during te rewarming period. One possibility is that&#xD;
      the increased vasodilatation resulting from glyceryl trinitrate may divert most of the heat&#xD;
      to the body and protect the brain from overheating. The other possibility is that the&#xD;
      increased partial pressures of carbon dioxide may render the brain more susceptible to the&#xD;
      vasodilatatory actions of glyceryl trinitrate, which may cause the brain to overheat.&#xD;
&#xD;
      This study will measure temperatures at several sites of the patient and the cardiopulmonary&#xD;
      bypass machine:&#xD;
&#xD;
        -  Nasopharynx: a probe inside the nasal cavity, located above the palate.&#xD;
&#xD;
        -  Core temperature: a probe inside the esophagus, 12 cm distal from where the heart and&#xD;
           breath sounds are heard best.&#xD;
&#xD;
        -  Heat-exchanger: recorded as is supplied by the heat exchanger as the temperature of the&#xD;
           water inside the heat exchanger.&#xD;
&#xD;
        -  Returning blood: measured at the entrance of reservoir&#xD;
&#xD;
        -  Blood leaving the oxygenator: measured at the outlet of the oxygenator&#xD;
&#xD;
      All patients scheduled for cardiopulmonary bypass grafting surgery, and aortic arch surgery&#xD;
      will be recruited.&#xD;
&#xD;
      Data will be collected by an observer blinded to the glyceryl trinitrate dose used. Data&#xD;
      management will be done via an electronic database including demographic data, anesthetic&#xD;
      records, and bypass records of the patient. All data will be anonymized on a case-by-case&#xD;
      fashion after the surgery. Data analysis will be performed using R statistical software.&#xD;
&#xD;
      Any adverse events, including adverse drug reactions, and adverse patient outcomes associated&#xD;
      with monitoring tools and patient management will be reported to the Ethics Committee. Should&#xD;
      any change to the research protocol required, the Ethics Committee will be informed.&#xD;
&#xD;
      Sample size for each sample is calculated (according to the primary outcomes of the study) as&#xD;
      48 to detect a 20 % difference in time to reach optimal body temperature (expected mean 30 ±&#xD;
      5 minutes, or a 0.3 °C difference in nasopharyngeal temperature when the esophageal&#xD;
      temperature reached 37 °C.&#xD;
&#xD;
      In case of missing data (such as due to equipment malfunction, inability to monitor the&#xD;
      patient, data not reported, uninterpretable, or considered missing because of data&#xD;
      inconsistency or out-of-range results), the participant will be excluded from the study.&#xD;
&#xD;
      The statistical analysis will include descriptive statistics of patient demographics,&#xD;
      comparison of both primary outcomes, and comparisons of adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">November 22, 2017</completion_date>
  <primary_completion_date type="Actual">November 22, 2017</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Intervention type is drug dosage. Patients will be assigned to 2 arms, where they will receive different doses of the same drug. The study will end when both of the arms will have at least 48 patients each.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The randomization will be via enclosed envelope technique. The anesthetic management of the patient will be provided by an anesthesiologist other than the investigator. This anesthesiologist will not be blinded to the dose of the study drug, and will be responsible from the administration of the appropriate dose of the study drug.&#xD;
The perfusionist, who is the main care provider during the rewarming period of the cardiopulmonary bypass, will be blinded to the dose of the study drug.&#xD;
The investigator will be blinded, and will be responsible from the collection, and validation of the data.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Nasopharyngeal temperature &gt; 37 °C</measure>
    <time_frame>Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes</time_frame>
    <description>If the nasopharyngeal temperature is &gt; 37 °C by the time the esophageal temperature reached 37 °C.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to 37 °C</measure>
    <time_frame>Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes</time_frame>
    <description>Time required to reach an esophageal temperature of 37 °C.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event: Regional cerebral oxygen saturation</measure>
    <time_frame>Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes</time_frame>
    <description>Occurrence and degree of significant drop in regional cerebral oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Intensive Care Unit stay</measure>
    <time_frame>Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from Intensive Care Unit, whichever came first, assessed up to 1 month</time_frame>
    <description>Outcome criteria for coronary artery bypass surgery: length of intensive care unit stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months</time_frame>
    <description>Outcome criteria for coronary artery bypass surgery: length of intensive care unit stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of atrial fibrillation</measure>
    <time_frame>Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months</time_frame>
    <description>Outcome criteria for coronary artery bypass surgery: occurrence of atrial fibrillation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of low cardiac output syndrome</measure>
    <time_frame>Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months</time_frame>
    <description>Outcome criteria for coronary artery bypass surgery: occurrence of low cardiac output syndrome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of stroke</measure>
    <time_frame>Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months</time_frame>
    <description>Outcome criteria for coronary artery bypass surgery: occurrence of stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of delirium</measure>
    <time_frame>Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months</time_frame>
    <description>Outcome criteria for coronary artery bypass surgery: occurrence of postoperative delirium</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Coronary Artery Bypass</condition>
  <condition>Cardiopulmonary Bypass</condition>
  <arm_group>
    <arm_group_label>Glyceryl trinitrate 0.2</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Drug Intervention Generic name: Glyceryl trinitrate Dosage form: Ampoule for intravenous infusion Dosage: 0.2 mcg/kg/minute Frequency and duration: The infusion will start as soon as the rewarming period starts, will continue throughout the operation and throughout the first 24 hours of the postoperative period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glyceryl trinitrate 0.5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug Intervention Generic name: Glyceryl trinitrate Dosage form: Ampoule for intravenous infusion Dosage: 0.5 mcg/kg/minute Frequency and duration: The infusion will start as soon as the rewarming period starts, will continue throughout the operation and throughout the first 24 hours of the postoperative period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glyceryl trinitrate 0.2</intervention_name>
    <description>These patients will receive glyceryl trinitrate infusion at a rate of 0.2 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.</description>
    <arm_group_label>Glyceryl trinitrate 0.2</arm_group_label>
    <other_name>Nitroglycerin, Perlinganit</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glyceryl trinitrate 0.5</intervention_name>
    <description>These patients will receive glyceryl trinitrate infusion at a rate of 0.5 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.</description>
    <arm_group_label>Glyceryl trinitrate 0.5</arm_group_label>
    <other_name>Nitroglycerin, Perlinganit</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who are scheduled for on-pump coronary artery bypass grafting surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Administration of vasopressors during rewarming period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Başar Erdivanlı, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Recep Tayyip Erdogan University Medical Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Recep Tayyip Erdogan University, Medical Faculty</name>
      <address>
        <city>Rize</city>
        <zip>53100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Johansson BW. The hibernator heart--nature's model of resistance to ventricular fibrillation. Cardiovasc Res. 1996 May;31(5):826-32. doi: 10.1016/0008-6363(95)00192-1.</citation>
    <PMID>8763414</PMID>
  </reference>
  <reference>
    <citation>Michenfelder JD, Milde JH. The relationship among canine brain temperature, metabolism, and function during hypothermia. Anesthesiology. 1991 Jul;75(1):130-6. doi: 10.1097/00000542-199107000-00021.</citation>
    <PMID>2064037</PMID>
  </reference>
  <reference>
    <citation>Hori D, Everett AD, Lee JK, Ono M, Brown CH, Shah AS, Mandal K, Price JE, Lester LC, Hogue CW. Rewarming Rate During Cardiopulmonary Bypass Is Associated With Release of Glial Fibrillary Acidic Protein. Ann Thorac Surg. 2015 Oct;100(4):1353-8. doi: 10.1016/j.athoracsur.2015.04.006. Epub 2015 Jul 7.</citation>
    <PMID>26163357</PMID>
  </reference>
  <reference>
    <citation>Engelman R, Hammon JW, Baker RA, Shore-Lesserson L. Rapid Rewarming During Cardiopulmonary Bypass Is Associated With Cerebral Injury. Ann Thorac Surg. 2016 May;101(5):2026-7. doi: 10.1016/j.athoracsur.2015.11.021. No abstract available.</citation>
    <PMID>27106452</PMID>
  </reference>
  <reference>
    <citation>Grigore AM, Grocott HP, Mathew JP, Phillips-Bute B, Stanley TO, Butler A, Landolfo KP, Reves JG, Blumenthal JA, Newman MF; Neurologic Outcome Research Group of the Duke Heart Center. The rewarming rate and increased peak temperature alter neurocognitive outcome after cardiac surgery. Anesth Analg. 2002 Jan;94(1):4-10, table of contents. doi: 10.1097/00000539-200201000-00002.</citation>
    <PMID>11772792</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rize Üniversitesi</investigator_affiliation>
    <investigator_full_name>Başar Erdivanlı</investigator_full_name>
    <investigator_title>Asst. Prof. of Anesthesiology and Reanimation</investigator_title>
  </responsible_party>
  <keyword>peak temperature</keyword>
  <keyword>rewarming rate</keyword>
  <keyword>surgical outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitroglycerin</mesh_term>
  </intervention_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/NCT03251599
org study id: 2017/5
nct id: NCT03251599
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Glyceryl trinitrate is used in coronary artery bypass grafting surgery. This surgery
      frequently employs hypothermic cardiopulmonary bypass, where the whole body is cooled down to
      28-32 °C to arrest the heart, and protect the organs from ischemic insult. When the cardiac
      repair or grafting is done, the body is warmed to 37 °C. During this "rewarming period", the
      heart has to beat against the vessels, all of which are constricted due to hypothermia.

      To overcome this constriction of the vessels, and decrease the workload of the heart,
      glyceryl trinitrate is infused. This drug causes significant dilatation in arteries and
      veins, which allows the heart to pump the blood with less force. The dilatation of the
      vessels also allows the body to rewarm more easily.

      The investigators' concern is whether increased infusion rates of glyceryl trinitrate may
      cause uncontrolled rewarming of the brain or not. The investigators will measure the
      temperature of the brain using a temperature probe located in the nasal cavity. The
      temperature will be recorded at each minute during the the rewarming period. Results of two
      commonly used infusion rates of glyceryl trinitrate will be compared.
Hypothermia had demonstrated potential benefits in myocardial infarction, organ
      transplantation, and cardiopulmonary bypass. The brain uses 2/3 of the oxygen it receives to
      support cerebral electrophysiological function, while the rest is used for maintenance of
      cellular integrity. Anesthetic drugs alter only the first portion, while temperature is the
      only agent known to affect both portions (the cerebral consumption of oxygen decreases 6-7 %
      per degree centigrade reduction in temperature).

      Although hypothermia is effectively used to protect the brain and myocardium from ischemia,
      studies report that rapid rewarming is correlated with brain injury. Therefore it is common
      practice to monitor the nasopharyngeal temperature and to keep the gradient between
      heat-exchanger and nasopharynx during rewarming at 2-3 °C.

      This study's main concern is that the infusion rate of glyceryl trinitrate may affect the
      rewarming rate of the body and the brain during te rewarming period. One possibility is that
      the increased vasodilatation resulting from glyceryl trinitrate may divert most of the heat
      to the body and protect the brain from overheating. The other possibility is that the
      increased partial pressures of carbon dioxide may render the brain more susceptible to the
      vasodilatatory actions of glyceryl trinitrate, which may cause the brain to overheat.

      This study will measure temperatures at several sites of the patient and the cardiopulmonary
      bypass machine:

        -  Nasopharynx: a probe inside the nasal cavity, located above the palate.

        -  Core temperature: a probe inside the esophagus, 12 cm distal from where the heart and
           breath sounds are heard best.

        -  Heat-exchanger: recorded as is supplied by the heat exchanger as the temperature of the
           water inside the heat exchanger.

        -  Returning blood: measured at the entrance of reservoir

        -  Blood leaving the oxygenator: measured at the outlet of the oxygenator

      All patients scheduled for cardiopulmonary bypass grafting surgery, and aortic arch surgery
      will be recruited.

      Data will be collected by an observer blinded to the glyceryl trinitrate dose used. Data
      management will be done via an electronic database including demographic data, anesthetic
      records, and bypass records of the patient. All data will be anonymized on a case-by-case
      fashion after the surgery. Data analysis will be performed using R statistical software.

      Any adverse events, including adverse drug reactions, and adverse patient outcomes associated
      with monitoring tools and patient management will be reported to the Ethics Committee. Should
      any change to the research protocol required, the Ethics Committee will be informed.

      Sample size for each sample is calculated (according to the primary outcomes of the study) as
      48 to detect a 20 % difference in time to reach optimal body temperature (expected mean 30 ±
      5 minutes, or a 0.3 °C difference in nasopharyngeal temperature when the esophageal
      temperature reached 37 °C.

      In case of missing data (such as due to equipment malfunction, inability to monitor the
      patient, data not reported, uninterpretable, or considered missing because of data
      inconsistency or out-of-range results), the participant will be excluded from the study.

      The statistical analysis will include descriptive statistics of patient demographics,
      comparison of both primary outcomes, and comparisons of adverse events.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention type is drug dosage. Patients will be assigned to 2 arms, where they will receive different doses of the same drug. The study will end when both of the arms will have at least 48 patients each.
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The randomization will be via enclosed envelope technique. The anesthetic management of the patient will be provided by an anesthesiologist other than the investigator. This anesthesiologist will not be blinded to the dose of the study drug, and will be responsible from the administration of the appropriate dose of the study drug.
The perfusionist, who is the main care provider during the rewarming period of the cardiopulmonary bypass, will be blinded to the dose of the study drug.
The investigator will be blinded, and will be responsible from the collection, and validation of the data.
measure: Nasopharyngeal temperature > 37 °C
time frame: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
description: If the nasopharyngeal temperature is > 37 °C by the time the esophageal temperature reached 37 °C.
measure: Time to 37 °C
time frame: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
description: Time required to reach an esophageal temperature of 37 °C.
measure: Adverse event: Regional cerebral oxygen saturation
time frame: Rewarming period of cardiopulmonary bypass, usually 30 - 45 minutes
description: Occurrence and degree of significant drop in regional cerebral oxygen saturation
measure: Length of Intensive Care Unit stay
time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from Intensive Care Unit, whichever came first, assessed up to 1 month
description: Outcome criteria for coronary artery bypass surgery: length of intensive care unit stay
measure: Length of hospital stay
time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
description: Outcome criteria for coronary artery bypass surgery: length of intensive care unit stay
measure: Frequency of atrial fibrillation
time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
description: Outcome criteria for coronary artery bypass surgery: occurrence of atrial fibrillation
measure: Frequency of low cardiac output syndrome
time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
description: Outcome criteria for coronary artery bypass surgery: occurrence of low cardiac output syndrome
measure: Frequency of stroke
time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
description: Outcome criteria for coronary artery bypass surgery: occurrence of stroke
measure: Frequency of delirium
time frame: Postoperative period from entrance to Intensive Care Unit until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 3 months
description: Outcome criteria for coronary artery bypass surgery: occurrence of postoperative delirium
arm group label: Glyceryl trinitrate 0.2
arm group type: Sham Comparator
description: Drug Intervention Generic name: Glyceryl trinitrate Dosage form: Ampoule for intravenous infusion Dosage: 0.2 mcg/kg/minute Frequency and duration: The infusion will start as soon as the rewarming period starts, will continue throughout the operation and throughout the first 24 hours of the postoperative period.
arm group label: Glyceryl trinitrate 0.5
arm group type: Active Comparator
description: Drug Intervention Generic name: Glyceryl trinitrate Dosage form: Ampoule for intravenous infusion Dosage: 0.5 mcg/kg/minute Frequency and duration: The infusion will start as soon as the rewarming period starts, will continue throughout the operation and throughout the first 24 hours of the postoperative period.
intervention type: Drug
intervention name: Glyceryl trinitrate 0.2
description: These patients will receive glyceryl trinitrate infusion at a rate of 0.2 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.
arm group label: Glyceryl trinitrate 0.2
other name: Nitroglycerin, Perlinganit
intervention type: Drug
intervention name: Glyceryl trinitrate 0.5
description: These patients will receive glyceryl trinitrate infusion at a rate of 0.5 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.
arm group label: Glyceryl trinitrate 0.5
other name: Nitroglycerin, Perlinganit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Başar Erdivanlı, M.D.
role: Principal Investigator
affiliation: Recep Tayyip Erdogan University Medical Faculty
facility: 
country: Turkey
citation: Johansson BW. The hibernator heart--nature's model of resistance to ventricular fibrillation. Cardiovasc Res. 1996 May;31(5):826-32. doi: 10.1016/0008-6363(95)00192-1.
PMID: 8763414
citation: Michenfelder JD, Milde JH. The relationship among canine brain temperature, metabolism, and function during hypothermia. Anesthesiology. 1991 Jul;75(1):130-6. doi: 10.1097/00000542-199107000-00021.
PMID: 2064037
citation: Hori D, Everett AD, Lee JK, Ono M, Brown CH, Shah AS, Mandal K, Price JE, Lester LC, Hogue CW. Rewarming Rate During Cardiopulmonary Bypass Is Associated With Release of Glial Fibrillary Acidic Protein. Ann Thorac Surg. 2015 Oct;100(4):1353-8. doi: 10.1016/j.athoracsur.2015.04.006. Epub 2015 Jul 7.
PMID: 26163357
citation: Engelman R, Hammon JW, Baker RA, Shore-Lesserson L. Rapid Rewarming During Cardiopulmonary Bypass Is Associated With Cerebral Injury. Ann Thorac Surg. 2016 May;101(5):2026-7. doi: 10.1016/j.athoracsur.2015.11.021. No abstract available.
PMID: 27106452
citation: Grigore AM, Grocott HP, Mathew JP, Phillips-Bute B, Stanley TO, Butler A, Landolfo KP, Reves JG, Blumenthal JA, Newman MF; Neurologic Outcome Research Group of the Duke Heart Center. The rewarming rate and increased peak temperature alter neurocognitive outcome after cardiac surgery. Anesth Analg. 2002 Jan;94(1):4-10, table of contents. doi: 10.1097/00000539-200201000-00002.
PMID: 11772792
responsible party type: Principal Investigator
investigator affiliation: Rize Üniversitesi
investigator full name: Başar Erdivanlı
investigator title: Asst. Prof. of Anesthesiology and Reanimation
mesh term: Hypothermia
mesh term: Nitroglycerin
sharing ipd: No