<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/NCT02978066</url>
  </required_header>
  <id_info>
    <org_study_id>2010-2042-31/1</org_study_id>
    <nct_id>NCT02978066</nct_id>
  </id_info>
  <brief_title>Postspinal Hypotension and Cardiac Performance in the Elderly</brief_title>
  <official_title>Is Postspinal Hypotension a Sign of Impaired Cardiac Performance in the Elderly? An Observational Mechanistic Study</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>
      Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac&#xD;
      Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was&#xD;
      defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations&#xD;
      between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal&#xD;
      anesthesia were analysed by logistic regression analyses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Stroke volume in ml</measure>
    <time_frame>0-45 minutes after spinal anaesthesia</time_frame>
    <description>the blood volume pumped by the heart at each stroke</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial blood pressure mmHg and change from baseline</measure>
    <time_frame>0-45 minutes after spinal anaesthesia</time_frame>
    <description>mmHg measured by arterial catheter</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>ARTHROPLASTY, REPLACEMENT; ANESTHESIA</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spinal anaesthesia</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 65 years or older scheduled for hip or knee arthroplasty in spinal&#xD;
        anaesthesia. Exclusion criteria were: (i) weight &lt;40kg; (ii) concomitant lithium&#xD;
        medication; (iv) informed consent not obtained; (v) research team unavailable&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hip or knee arthroplasty&#xD;
&#xD;
          -  spinal anaesthesia&#xD;
&#xD;
          -  age 65 years or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  weight &lt;40kg&#xD;
&#xD;
          -  concomitant lithium medication&#xD;
&#xD;
          -  written informed consent not obtained&#xD;
&#xD;
          -  research team unavailable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</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>MD Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT02978066
org study id: 2010-2042-31/1
nct id: NCT02978066
lead sponsor: 
has dmc: No
Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac
      Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was
      defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations
      between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal
      anesthesia were analysed by logistic regression analyses.
observational model: Cohort
time perspective: Prospective
measure: Stroke volume in ml
time frame: 0-45 minutes after spinal anaesthesia
description: the blood volume pumped by the heart at each stroke
measure: Arterial blood pressure mmHg and change from baseline
time frame: 0-45 minutes after spinal anaesthesia
description: mmHg measured by arterial catheter
intervention type: Other
intervention name: Spinal anaesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Sigridur Kalman
investigator title: MD Professor
mesh term: Hypotension
mesh term: Anesthetics
sharing ipd: No