<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/NCT02224222</url>
  </required_header>
  <id_info>
    <org_study_id>VSZÉK-FRAILTY</org_study_id>
    <nct_id>NCT02224222</nct_id>
  </id_info>
  <brief_title>Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery</brief_title>
  <official_title>Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University Heart and Vascular Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Semmelweis University Heart and Vascular Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the impact of frailty as a multidimensional risk&#xD;
      factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining&#xD;
      patient frailty a multimodal questionnaire has been developed including measurement of&#xD;
      psychological, socioeconomical, neurological and behavioral aspects. This study also features&#xD;
      an investigation of the possible relationship between sudden regional weather changes,&#xD;
      individual meteorological susceptibility of the patients and the outcomes of adult cardiac&#xD;
      and vascular surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Length of hospital and intensive care unit stay.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The composite of in-hospital death from any cause.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of clinically definite postoperative acute kidney injury and the need for dialysis.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of clinically definite postoperative low cardiac output syndrome.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of clinically definite postoperative cardiac arrythmias.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of clinically definite postoperative SIRS.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of clinically definite postoperative acute lung injury and the need for mechanical ventilation.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of clinically definite postoperative peripheral vascular insufficiency.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The need for reoperation due to bleeding.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Intellectual Frailty of Aging</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Vascular Diseases</condition>
  <condition>Heart; Dysfunction Postoperative, Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Patients undergoing vascular procedures</arm_group_label>
    <description>Including all non-interventional surgical procedures, excluding varix surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients undergoing cardiac procedures</arm_group_label>
    <description>Including all non-interventional surgical procedures, excluding HTX</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive evaluable patients, 18 years old or older, admitted to Semmelweis University,&#xD;
        Heart and Vascular Center for elective cardiac or vascular surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, 18 years or older, admitted to the hospital for elective cardiac or vascular&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to participate.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  During active psychiatric hospital care.&#xD;
&#xD;
          -  Patients with defined legal incapability or limited capability.&#xD;
&#xD;
          -  Congenital or acquired speech impediment and locomotion disability of any kind.&#xD;
&#xD;
          -  Non-evaluable patient due to communication problems and insufficient clinical&#xD;
             information for the judgement of frailty (CFS).&#xD;
&#xD;
          -  Patients admitted solely for elective surgery of the varices of the lower extremities.&#xD;
&#xD;
          -  Patients with a transplanted heart.&#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>Andrea Székely, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Semmelweis University, Department of Anesthesiology and Intensive Therapy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel J Lex, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University Heart and Vascular Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nikoletta Czobor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Misnyovszki</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanna Tihanyi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kalatin Fink, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Béla Merkely, MD, PhD, DSc</last_name>
    <role>Study Chair</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>László Entz, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zoltán Szabolcs, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>János Gál, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Erzsébet Paulovich, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eniko Holndonner-Kirst, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Semmelweis University, Heart and Vascular Center</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>April 6, 2019</last_update_submitted>
  <last_update_submitted_qc>April 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Semmelweis University</investigator_affiliation>
    <investigator_full_name>Andrea Szekely</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Frailty</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/NCT02224222
org study id: VSZÉK-FRAILTY
nct id: NCT02224222
lead sponsor: 
has dmc: No
The purpose of this study is to assess the impact of frailty as a multidimensional risk
      factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining
      patient frailty a multimodal questionnaire has been developed including measurement of
      psychological, socioeconomical, neurological and behavioral aspects. This study also features
      an investigation of the possible relationship between sudden regional weather changes,
      individual meteorological susceptibility of the patients and the outcomes of adult cardiac
      and vascular surgery.
observational model: Cohort
time perspective: Prospective
measure: Length of hospital and intensive care unit stay.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: The composite of in-hospital death from any cause.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative acute kidney injury and the need for dialysis.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative low cardiac output syndrome.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative cardiac arrythmias.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative SIRS.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative acute lung injury and the need for mechanical ventilation.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: Evidence of clinically definite postoperative peripheral vascular insufficiency.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: The need for reoperation due to bleeding.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
arm group label: Patients undergoing vascular procedures
description: Including all non-interventional surgical procedures, excluding varix surgery
arm group label: Patients undergoing cardiac procedures
description: Including all non-interventional surgical procedures, excluding HTX
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Székely, MD, PhD
role: Study Director
affiliation: Semmelweis University, Department of Anesthesiology and Intensive Therapy
last name: Daniel J Lex, MD
role: Principal Investigator
affiliation: Semmelweis University Heart and Vascular Center
last name: Nikoletta Czobor
role: Principal Investigator
affiliation: Semmelweis University
last name: Peter Misnyovszki
role: Principal Investigator
affiliation: Semmelweis University
last name: Hanna Tihanyi
role: Principal Investigator
affiliation: Semmelweis University
last name: Kalatin Fink, MD
role: Principal Investigator
affiliation: Semmelweis University
last name: Béla Merkely, MD, PhD, DSc
role: Study Chair
affiliation: Semmelweis University
last name: László Entz, MD, PhD
role: Study Chair
affiliation: Semmelweis University
last name: Zoltán Szabolcs, MD, PhD
role: Study Chair
affiliation: Semmelweis University
last name: János Gál, MD, PhD
role: Study Chair
affiliation: Semmelweis University
last name: Erzsébet Paulovich, MD
role: Study Chair
affiliation: Semmelweis University
last name: Eniko Holndonner-Kirst, MD
role: Principal Investigator
affiliation: Semmelweis University
facility: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Semmelweis University
investigator full name: Andrea Szekely
investigator title: Associate professor
mesh term: Cardiovascular Diseases
mesh term: Myocardial Infarction
mesh term: Vascular Diseases
mesh term: Infarction
mesh term: Frailty