<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/NCT03014765</url>
  </required_header>
  <id_info>
    <org_study_id>MZ 0120-446/2015-2</org_study_id>
    <nct_id>NCT03014765</nct_id>
  </id_info>
  <brief_title>Endothelial Dysfunction in Perioperative Period</brief_title>
  <acronym>EDOP</acronym>
  <official_title>Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Loyola University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Centre Ljubljana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated&#xD;
      dilatation capability (FMD) of the brachial artery will be measured prior to elective&#xD;
      surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the&#xD;
      brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds after&#xD;
      cuff deflation. From above mentioned values the increase in the diameter of the artery during&#xD;
      reactive hyperemia will be calculated.&#xD;
&#xD;
      Simultaneously with the ultrasound investigations, the blood for determination of the&#xD;
      endothelial dysfunction markers will be collected.&#xD;
&#xD;
      The participants will be contacted again 3 months after the surgery and asked about the&#xD;
      complications which may be associated with the surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular complications, especially coronary heart disease, are one of the main causes&#xD;
      of perioperative complications. Indicators of pre-clinical atherosclerosis, such as:&#xD;
      endothelial dysfunction, increased arterial intima/media thickness (especially in the carotid&#xD;
      arteries), carotid calcification and coronary calcification, suggest the presence of&#xD;
      atherosclerotic process without the symptomatic presentation. Endothelial dysfunction is one&#xD;
      of the earliest measurable changes that predict the development of atherosclerotic disease.&#xD;
&#xD;
      Surgery is a significant stress for the organism: it increases the release of free oxygen&#xD;
      radicals and through oxidative stress it increases systemic inflammatory response and causes&#xD;
      thromboembolic complications.&#xD;
&#xD;
      In the study 50 patients of both sexes 40-80 years of age scheduled for hip arthroplasty will&#xD;
      be included. In each subject a flow-mediated dilatation capability (FMD) of the brachial&#xD;
      artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days&#xD;
      after surgery. Measurement of the brachial artery flow-mediated dilatation capability (FMD):&#xD;
      the brachial artery diameter will be measured 5 cm proximal to the antecubital fossa at rest,&#xD;
      during cuff inflation and 50 seconds after cuff deflation. The cuff will be inflated for 4&#xD;
      min. From above mentioned values the increase in the diameter of the artery during reactive&#xD;
      hyperemia will be calculated.&#xD;
&#xD;
      Simultaneously with the ultrasound investigations, the blood for determination of the&#xD;
      inflammatory and endothelial dysfunction markers (CRP, IL-6, IL-8, IL-10, IL-18, TNFa, VW&#xD;
      Factor, Selectin P, selectin E) will be collected.&#xD;
&#xD;
      The participants will be contacted again 3 months after the surgery and asked about the&#xD;
      complications which may be associated with the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">December 8, 2017</completion_date>
  <primary_completion_date type="Actual">June 16, 2017</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>rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>levels of blood circulating markers of increased perioperative stress and systemic inflammatory response</measure>
    <time_frame>12 months</time_frame>
    <description>levels of vWF, selectin P, selectin E, IL-6, IL-8, IL-10, IL-18, TNFa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>decrease in endothelial function</measure>
    <time_frame>12 months</time_frame>
    <description>reduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values</description>
  </secondary_outcome>
  <enrollment type="Actual">70</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <condition>Postoperative Complications</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EDOP</intervention_name>
    <description>no intervention</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled hip arthroplasty under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute coronary syndrome or cerebrovascular syndrome in the last 6 months&#xD;
&#xD;
          -  Acute venous thrombosis in the last 6 months&#xD;
&#xD;
          -  Episode of rheumatoid arthritis in the last 3 months or permanent therapy with&#xD;
             prednisolone &gt;4mg/day&#xD;
&#xD;
          -  Acute illness or hospitalization in the last month&#xD;
&#xD;
          -  Chronic kidney failure on dialysis&#xD;
&#xD;
          -  Hepatic failure&#xD;
&#xD;
          -  Active malignant disease&#xD;
&#xD;
          -  Immunosuppression after organ transplantation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  No informed consent after oral and written information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Peter Poredos</investigator_full_name>
    <investigator_title>Head of Orthopaedic Anaesthesia</investigator_title>
  </responsible_party>
  <keyword>endothelial dysfunction</keyword>
  <keyword>perioperative stress</keyword>
  <keyword>cardiovascular complications</keyword>
  <keyword>inflammatory markers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</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/NCT03014765
org study id: MZ 0120-446/2015-2
nct id: NCT03014765
lead sponsor: 
collaborator: 
has dmc: No
Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated
      dilatation capability (FMD) of the brachial artery will be measured prior to elective
      surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the
      brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds after
      cuff deflation. From above mentioned values the increase in the diameter of the artery during
      reactive hyperemia will be calculated.

      Simultaneously with the ultrasound investigations, the blood for determination of the
      endothelial dysfunction markers will be collected.

      The participants will be contacted again 3 months after the surgery and asked about the
      complications which may be associated with the surgery.
Cardiovascular complications, especially coronary heart disease, are one of the main causes
      of perioperative complications. Indicators of pre-clinical atherosclerosis, such as:
      endothelial dysfunction, increased arterial intima/media thickness (especially in the carotid
      arteries), carotid calcification and coronary calcification, suggest the presence of
      atherosclerotic process without the symptomatic presentation. Endothelial dysfunction is one
      of the earliest measurable changes that predict the development of atherosclerotic disease.

      Surgery is a significant stress for the organism: it increases the release of free oxygen
      radicals and through oxidative stress it increases systemic inflammatory response and causes
      thromboembolic complications.

      In the study 50 patients of both sexes 40-80 years of age scheduled for hip arthroplasty will
      be included. In each subject a flow-mediated dilatation capability (FMD) of the brachial
      artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days
      after surgery. Measurement of the brachial artery flow-mediated dilatation capability (FMD):
      the brachial artery diameter will be measured 5 cm proximal to the antecubital fossa at rest,
      during cuff inflation and 50 seconds after cuff deflation. The cuff will be inflated for 4
      min. From above mentioned values the increase in the diameter of the artery during reactive
      hyperemia will be calculated.

      Simultaneously with the ultrasound investigations, the blood for determination of the
      inflammatory and endothelial dysfunction markers (CRP, IL-6, IL-8, IL-10, IL-18, TNFa, VW
      Factor, Selectin P, selectin E) will be collected.

      The participants will be contacted again 3 months after the surgery and asked about the
      complications which may be associated with the surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction
time frame: 12 months
measure: levels of blood circulating markers of increased perioperative stress and systemic inflammatory response
time frame: 12 months
description: levels of vWF, selectin P, selectin E, IL-6, IL-8, IL-10, IL-18, TNFa
measure: decrease in endothelial function
time frame: 12 months
description: reduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values
intervention type: Other
intervention name: EDOP
description: no intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Peter Poredos
investigator title: Head of Orthopaedic Anaesthesia
mesh term: Postoperative Complications
sharing ipd: No