<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/NCT01698125</url>
  </required_header>
  <id_info>
    <org_study_id>2011/2498/REK nord</org_study_id>
    <nct_id>NCT01698125</nct_id>
  </id_info>
  <brief_title>Autonomic Cardiovascular Control for Elderly Surgery Patients</brief_title>
  <official_title>Autonomic Cardiovascular Control for Elderly Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South-Eastern Norway Regional Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to study aspects of autonomic cardiovascular control and the&#xD;
      level of stress hormones and inflammatory markers in saliva or serum, in elderly patients&#xD;
      exposed to elective, major abdominal surgery, with or without postoperative delirium, to&#xD;
      explore the hypothesis that delirium may be the result of aberrant stress responses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients admitted for elective, major, abdominal surgery will be tested with a head-up&#xD;
      tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative&#xD;
      day. Haemodynamic variables will be registered by the device TaskForceMonitor which monitors&#xD;
      heart rate (HR), electrocardiography (ECG), blood pressure and stroke volume continuously and&#xD;
      non-invasively.&#xD;
&#xD;
      Background variables (including demographics, comorbidity and simple cognitive tests) and&#xD;
      daily variables (including delirium assessments) will be registered.&#xD;
&#xD;
      Blood and saliva samples will be drawn preoperatively and postoperatively to measure levels&#xD;
      of stress hormones and inflammatory markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Practical circumstances made it too difficult to carry out as planned.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Change in orthostatic cardiovascular responses</measure>
    <time_frame>Baseline and postoperatively at surgical ward (expected second postoperative day)</time_frame>
    <description>Change in orthostatic cardiovascular responses (head-up tilt test) pre- and postoperatively in patients with and without postoperative delirium will be evaluated based on measurements of heart rate, systolic blood pressure (BP), mean BP, diastolic BP, stroke index, total peripheral resistance index, end-diastolic volume index, and acceleration index.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barthel Activities of Daily Living (ADL) Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Score from 0-20 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nottingham Extended Activity of Daily Living (NEADL) Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Score from 0-66 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Illness Rating Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Total score from 0-56.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dementia</measure>
    <time_frame>Baseline</time_frame>
    <description>Simple cognitive tests preformed preoperatively, including MMSE, Clock Drawing Test, Trail making A and B and Ten word memory test. Also IQCODE when reliable information is present.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium</measure>
    <time_frame>Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.</time_frame>
    <description>Daily assessing the patient using the Confusion Assessment Method (CAM), shortened version.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol</measure>
    <time_frame>Baseline and second postoperative day</time_frame>
    <description>Looking for differences in levels of cortisol in saliva (morning samples) pre-and postoperatively in patients developing delirium compared to patients not developing delirium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of delirium</measure>
    <time_frame>Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days</time_frame>
    <description>Daily assessing the patient using MDAS (the memorial delirium assessment scale). Total score from 0-30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait speed</measure>
    <time_frame>Baseline</time_frame>
    <description>Measuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Abdominal surgery</arm_group_label>
    <description>Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Abdominal surgery</intervention_name>
    <description>Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital</description>
    <arm_group_label>Abdominal surgery</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum. Plasma. Saliva.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for abdominal surgery at Oslo University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of a valid informed consent or assent, or consent from a legal proxy&#xD;
&#xD;
          -  Patients with atrial fibrillation or a pacemaker rhythm&#xD;
&#xD;
          -  Polyneuropathy&#xD;
&#xD;
          -  Current treatment with beta-blockers, calcium-blockers or cholinesterase inhibitors&#xD;
&#xD;
          -  Competing research project&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torgeir B Wyller, MD, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital, Ullevaal</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>April 14, 2014</last_update_submitted>
  <last_update_submitted_qc>April 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Delirium</keyword>
  <keyword>Autonomic cardiovascular control</keyword>
  <keyword>Abdominal surgery</keyword>
  <keyword>Tilt-test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</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/NCT01698125
org study id: 2011/2498/REK nord
nct id: NCT01698125
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to study aspects of autonomic cardiovascular control and the
      level of stress hormones and inflammatory markers in saliva or serum, in elderly patients
      exposed to elective, major abdominal surgery, with or without postoperative delirium, to
      explore the hypothesis that delirium may be the result of aberrant stress responses.
Patients admitted for elective, major, abdominal surgery will be tested with a head-up
      tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative
      day. Haemodynamic variables will be registered by the device TaskForceMonitor which monitors
      heart rate (HR), electrocardiography (ECG), blood pressure and stroke volume continuously and
      non-invasively.

      Background variables (including demographics, comorbidity and simple cognitive tests) and
      daily variables (including delirium assessments) will be registered.

      Blood and saliva samples will be drawn preoperatively and postoperatively to measure levels
      of stress hormones and inflammatory markers.
observational model: Cohort
time perspective: Prospective
measure: Change in orthostatic cardiovascular responses
time frame: Baseline and postoperatively at surgical ward (expected second postoperative day)
description: Change in orthostatic cardiovascular responses (head-up tilt test) pre- and postoperatively in patients with and without postoperative delirium will be evaluated based on measurements of heart rate, systolic blood pressure (BP), mean BP, diastolic BP, stroke index, total peripheral resistance index, end-diastolic volume index, and acceleration index.
measure: Barthel Activities of Daily Living (ADL) Scale
time frame: Baseline
description: Score from 0-20 points
measure: Nottingham Extended Activity of Daily Living (NEADL) Scale
time frame: Baseline
description: Score from 0-66 points.
measure: Cumulative Illness Rating Scale
time frame: Baseline
description: Total score from 0-56.
measure: Dementia
time frame: Baseline
description: Simple cognitive tests preformed preoperatively, including MMSE, Clock Drawing Test, Trail making A and B and Ten word memory test. Also IQCODE when reliable information is present.
measure: Delirium
time frame: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.
description: Daily assessing the patient using the Confusion Assessment Method (CAM), shortened version.
measure: Cortisol
time frame: Baseline and second postoperative day
description: Looking for differences in levels of cortisol in saliva (morning samples) pre-and postoperatively in patients developing delirium compared to patients not developing delirium.
measure: Severity of delirium
time frame: Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days
description: Daily assessing the patient using MDAS (the memorial delirium assessment scale). Total score from 0-30.
measure: Gait speed
time frame: Baseline
description: Measuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second.
arm group label: Abdominal surgery
description: Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
intervention type: Procedure
intervention name: Abdominal surgery
description: Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
arm group label: Abdominal surgery
Serum. Plasma. Saliva.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Torgeir B Wyller, MD, Prof
role: Study Director
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Delirium