<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/NCT02237833</url>
  </required_header>
  <id_info>
    <org_study_id>2014/194 REK</org_study_id>
    <nct_id>NCT02237833</nct_id>
  </id_info>
  <brief_title>Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study</brief_title>
  <acronym>CONSCIOUS</acronym>
  <official_title>Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karl-Andre Wian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sykehuset i Vestfold HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to reveal if higher doses of vasopressors in septic shock&#xD;
      patients correlates with cerebral vasoconstriction and lower cerebral oximetry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mortality with septic shock is high. Treatment includes antibiotics, intravenous fluid&#xD;
      and drugs for circulatory support, especially the vasopressor norepinephrine. Fluids and&#xD;
      drugs for circulatory support are to restore adequate organ perfusion. Inadequate oxygenation&#xD;
      of the brain can give neurologic damage. Traditionally treatment is guided by surrogate&#xD;
      markers like arterial and central venous pressure. Cerebral oximetry is a non-invasive method&#xD;
      which measures cerebral saturation of oxygen, SCO2, and thereby expresses regional cerebral&#xD;
      perfusion. By registering cerebral oxymetry on patients treated with vasopressors for septic&#xD;
      shock we want to reveal if higher doses of vasopressor correlates with cerebral&#xD;
      vasoconstriction and lower cerebral oximetry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Too slow recruitment.&#xD;
  </why_stopped>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>SCO2 will be measured before initiating vasopressor therapy. Thereafter SCO2 are updated every 2 seconds and is measured for 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute myocardial infarction</measure>
    <time_frame>Hospital discharge, expected 12 days at average</time_frame>
    <description>Incidence of acute myocardial infarction based on international criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of vasopressors/inotropes</measure>
    <time_frame>Discharge from ICU, expected 5 days at average</time_frame>
    <description>Use of vasopressors/inotropes&#xD;
norepinephrine&#xD;
epinephrine&#xD;
dopamine&#xD;
dobutamine&#xD;
vasopressin&#xD;
nitroprusside&#xD;
glyceryltrinitrate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid balance</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in ICU</measure>
    <time_frame>Discharge from ICU, expected 5 days at average</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>Discharge from hospital, expected 10 days at average</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of organ failure</measure>
    <time_frame>Discharge from ICU, expected 5 days at average</time_frame>
    <description>Measuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Septic shock and vasopressor</arm_group_label>
    <description>Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in the intensive care unit needing vasopressor for septic shock.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Septic shock patients in ICU department requiring vasopressor therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Damage to the frontal lobes corresponding to the area where SCO2 is monitored&#xD;
&#xD;
          -  Patients in pharmacological studies&#xD;
&#xD;
          -  Patients with known intracranial vascular anomalies or cerebral aneurysms&#xD;
&#xD;
          -  Patients where vasoactive medication is started before cerebral oxymetry is&#xD;
             established&#xD;
&#xD;
          -  Patients with known neurological disease&#xD;
&#xD;
          -  Patients with undergone cerebral insult, transient ischemic attack or carotid stenosis&#xD;
&#xD;
          -  Patients who have been resuscitated after cardiac arrest in connection with this&#xD;
             hospital stay&#xD;
&#xD;
          -  Patients with a body temperature below 35 degrees Celsius when establishing monitoring&#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>Karl-Andre Wian, cand.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Syekhuset Vestfold HF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sykehuset i Vestfold HF</name>
      <address>
        <city>Tonsberg</city>
        <state>Vestfold</state>
        <zip>N-3117</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>April 26, 2017</last_update_submitted>
  <last_update_submitted_qc>April 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sykehuset i Vestfold HF</investigator_affiliation>
    <investigator_full_name>Karl-Andre Wian</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>septic shock</keyword>
  <keyword>cerebral oximetry</keyword>
  <keyword>vasopressor</keyword>
  <keyword>norepinephrine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02237833
org study id: 2014/194 REK
nct id: NCT02237833
lead sponsor: 
has dmc: No
The purpose of this study is to reveal if higher doses of vasopressors in septic shock
      patients correlates with cerebral vasoconstriction and lower cerebral oximetry.
The mortality with septic shock is high. Treatment includes antibiotics, intravenous fluid
      and drugs for circulatory support, especially the vasopressor norepinephrine. Fluids and
      drugs for circulatory support are to restore adequate organ perfusion. Inadequate oxygenation
      of the brain can give neurologic damage. Traditionally treatment is guided by surrogate
      markers like arterial and central venous pressure. Cerebral oximetry is a non-invasive method
      which measures cerebral saturation of oxygen, SCO2, and thereby expresses regional cerebral
      perfusion. By registering cerebral oxymetry on patients treated with vasopressors for septic
      shock we want to reveal if higher doses of vasopressor correlates with cerebral
      vasoconstriction and lower cerebral oximetry.
observational model: Cohort
time perspective: Prospective
measure: Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours
time frame: 24 hours
description: SCO2 will be measured before initiating vasopressor therapy. Thereafter SCO2 are updated every 2 seconds and is measured for 24 hours.
measure: Incidence of acute myocardial infarction
time frame: Hospital discharge, expected 12 days at average
description: Incidence of acute myocardial infarction based on international criteria
measure: Use of vasopressors/inotropes
time frame: Discharge from ICU, expected 5 days at average
description: Use of vasopressors/inotropes
norepinephrine
epinephrine
dopamine
dobutamine
vasopressin
nitroprusside
glyceryltrinitrate
measure: Fluid balance
time frame: 24 hours
measure: Length of stay in ICU
time frame: Discharge from ICU, expected 5 days at average
measure: Length of stay in hospital
time frame: Discharge from hospital, expected 10 days at average
measure: Incidence of organ failure
time frame: Discharge from ICU, expected 5 days at average
description: Measuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.
arm group label: Septic shock and vasopressor
description: Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors.
Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karl-Andre Wian, cand.med.
role: Principal Investigator
affiliation: Syekhuset Vestfold HF
facility: 
country: Norway
responsible party type: Sponsor-Investigator
investigator affiliation: Sykehuset i Vestfold HF
investigator full name: Karl-Andre Wian
investigator title: MD
mesh term: Shock, Septic