<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/NCT03787810</url>
  </required_header>
  <id_info>
    <org_study_id>LEVEDYCIP</org_study_id>
    <nct_id>NCT03787810</nct_id>
  </id_info>
  <brief_title>Left Ventricular Dysfunction in Critically Ill Patients</brief_title>
  <acronym>LEVEDYCIP</acronym>
  <official_title>Left Ventricular Dysfunction in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Left ventricular dysfunction is common in the critically ill. The aim of this study is to&#xD;
      assess the incidence and prognosis of left ventricular dysfunction in critically ill&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Left ventricular dysfunction is common in the critically ill. A number of conditions can&#xD;
      cause left ventricular dysfunction including myocardial infarction, septic cardiomyopathy,&#xD;
      post resuscitation syndrome, takotsubo syndrome etc. A number of studies have assessed&#xD;
      cardiac dysfunction in specific conditions (e.g. sepsis, cardiac arrest) but only a few&#xD;
      studies have assessed cardiac dysfunction in a general ICU-population. The study will focus&#xD;
      on diagnostics of the different types of cardiomyopathy and differentiating between ischemic&#xD;
      and non-ischemic left ventricular dysfunction in a general ICU population. The aim of this&#xD;
      study is to assess the incidence and prognosis of the different types of left ventricular&#xD;
      dysfunction in critically ill patients. Our hypothesis is that left ventricular dysfunction&#xD;
      is common in the critically ill and is associated with an increased risk of short-term death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2018</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 2019</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>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>All cause mortality after admission to the ICU</description>
  </primary_outcome>
  <enrollment type="Actual">428</enrollment>
  <condition>Left Ventricular Dysfunction</condition>
  <condition>Critically Ill</condition>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Cardiomyopathies</condition>
  <condition>Takotsubo Cardiomyopathy</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Echocardiography for assessment of left ventricular dysfunction</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        General ICU population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted within 24 hours to the ICU&#xD;
&#xD;
          -  Dysfunction of at least one organ system, defined as at least +1 point in SOFA-score.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        -&#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>Jonatan Oras, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska Academy, University of Gothenburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <state>Västra Götalandsregionen</state>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>April 21, 2020</last_update_submitted>
  <last_update_submitted_qc>April 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Jonatan Oras</investigator_full_name>
    <investigator_title>Consultant, adjunct senior lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Left</mesh_term>
    <mesh_term>Takotsubo Cardiomyopathy</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Not decided</ipd_description>
  </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/NCT03787810
org study id: LEVEDYCIP
nct id: NCT03787810
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Left ventricular dysfunction is common in the critically ill. The aim of this study is to
      assess the incidence and prognosis of left ventricular dysfunction in critically ill
      patients.
Left ventricular dysfunction is common in the critically ill. A number of conditions can
      cause left ventricular dysfunction including myocardial infarction, septic cardiomyopathy,
      post resuscitation syndrome, takotsubo syndrome etc. A number of studies have assessed
      cardiac dysfunction in specific conditions (e.g. sepsis, cardiac arrest) but only a few
      studies have assessed cardiac dysfunction in a general ICU-population. The study will focus
      on diagnostics of the different types of cardiomyopathy and differentiating between ischemic
      and non-ischemic left ventricular dysfunction in a general ICU population. The aim of this
      study is to assess the incidence and prognosis of the different types of left ventricular
      dysfunction in critically ill patients. Our hypothesis is that left ventricular dysfunction
      is common in the critically ill and is associated with an increased risk of short-term death.
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: 30 days
description: All cause mortality after admission to the ICU
intervention type: Diagnostic Test
intervention name: Echocardiography
description: Echocardiography for assessment of left ventricular dysfunction
Blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonatan Oras, MD, PhD
role: Principal Investigator
affiliation: Sahlgrenska Academy, University of Gothenburg
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Jonatan Oras
investigator title: Consultant, adjunct senior lecturer
mesh term: Acute Coronary Syndrome
mesh term: Cardiomyopathies
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Left
mesh term: Takotsubo Cardiomyopathy
mesh term: Critical Illness
sharing ipd: Undecided
ipd description: Not decided