<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/NCT02977390</url>
  </required_header>
  <id_info>
    <org_study_id>ANE-HS 2013-06</org_study_id>
    <nct_id>NCT02977390</nct_id>
  </id_info>
  <brief_title>Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM</brief_title>
  <official_title>Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM to Guide Fluid Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to investigate whether patients at advanced age are fluid responders&#xD;
      via a reversible fluid challenge, the passive leg raise test. This will be measured with a&#xD;
      non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention is as simple as a passive leg raise with measurement of effect on Stroke&#xD;
      volume.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess passive leg raise responsiveness in spontaneously breathing aged patients.</measure>
    <time_frame>Within 1 minute of the intervention</time_frame>
    <description>Stroke volume changes in ml and as per cent change compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia.</measure>
    <time_frame>30 minutes</time_frame>
    <description>Post spinal bloodpressure per cent change or 30 mmHg decrease</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Stroke Volume</condition>
  <condition>Cardiovascular System</condition>
  <condition>Fluid Therapy</condition>
  <arm_group>
    <arm_group_label>Passive Leg Raise (PLR)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patient is placed in a 45 degree recumbent position. Stroke volume is measured in ml.&#xD;
Intervention:The patient is placed horizontal and the legs are passively raised to 45 degrees.&#xD;
Measurement:The effect of the PLR on Stroke Volume is measured. Thereafter the patient is repositioned to the initial position and Stroke Volume is measured again.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Passive leg raise</intervention_name>
    <description>By tilting the patient's bed from sitting 45 degrees to supine with legs tilted up 45 degrees we recruit the blood volume in the legs and can measure a reversible fluid challenge on stroke volume.</description>
    <arm_group_label>Passive Leg Raise (PLR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients ≥80 years of age, undergoing elective urologic surgical procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;80 years, severe aortic insufficiency, first case of the day on the operation&#xD;
             program, unavailability of research personnel and contraindication to Lithium.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>80 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sigridur Kalman, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Huddinge</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Sigridur Kalman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02977390
org study id: ANE-HS 2013-06
nct id: NCT02977390
lead sponsor: 
has dmc: No
This is a pilot study to investigate whether patients at advanced age are fluid responders
      via a reversible fluid challenge, the passive leg raise test. This will be measured with a
      non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .
The intervention is as simple as a passive leg raise with measurement of effect on Stroke
      volume.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Assess passive leg raise responsiveness in spontaneously breathing aged patients.
time frame: Within 1 minute of the intervention
description: Stroke volume changes in ml and as per cent change compared to baseline
measure: Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia.
time frame: 30 minutes
description: Post spinal bloodpressure per cent change or 30 mmHg decrease
arm group label: Passive Leg Raise (PLR)
arm group type: Other
description: The patient is placed in a 45 degree recumbent position. Stroke volume is measured in ml.
Intervention:The patient is placed horizontal and the legs are passively raised to 45 degrees.
Measurement:The effect of the PLR on Stroke Volume is measured. Thereafter the patient is repositioned to the initial position and Stroke Volume is measured again.
intervention type: Other
intervention name: Passive leg raise
description: By tilting the patient's bed from sitting 45 degrees to supine with legs tilted up 45 degrees we recruit the blood volume in the legs and can measure a reversible fluid challenge on stroke volume.
arm group label: Passive Leg Raise (PLR)
criteria: 
gender: All
minimum age: 80 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sigridur Kalman, Professor
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Sigridur Kalman
investigator title: Professor
mesh term: Stroke
sharing ipd: No