<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/NCT01704391</url>
  </required_header>
  <id_info>
    <org_study_id>S-20110154</org_study_id>
    <nct_id>NCT01704391</nct_id>
  </id_info>
  <brief_title>Haemodynamic Response to Aortic Surgery</brief_title>
  <official_title>Haemodynamic Response to Aortic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sygehus Lillebaelt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sygehus Lillebaelt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open elective abdominal aortic surgery is a high risk procedure involving clamping of the&#xD;
      aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD)&#xD;
      causing lower limb ischaemia.&#xD;
&#xD;
      These patients are often regarded as one entity in postoperative study settings. However,&#xD;
      previous studies indicate that risk profiles, inflammatory activity, and haemodynamic&#xD;
      capacity may differ between these groups. The first aim of this study was to evaluate&#xD;
      postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising&#xD;
      that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute&#xD;
      dialysis than did patients with AOD.&#xD;
&#xD;
      The investigators see a relatively high incidence of postoperative acute kidney injury (AKI)&#xD;
      following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in&#xD;
      the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of&#xD;
      inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory&#xD;
      response to aortic cross clamping may per se induce a rise in NGAL despite intact renal&#xD;
      function. Therefore NGAL may not be a reliable marker of AKI after AAS.&#xD;
&#xD;
      The second aim of this study is to describe the changes in NGAL after AAS in patients with&#xD;
      and without postoperative dialysis-dependent AKI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2013</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>ICU length of stay</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Number of patients with an ICU LOS &gt; 24 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative need for dialysis</measure>
    <time_frame>72 hours postoperatively</time_frame>
    <description>Number of patients developing dialysis dependency during the first 72 hours postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic peroperative changes in AAD vs AOD</measure>
    <time_frame>After anaesthesia induction, 10 minutes after aortic cross-clamping, 10 minutes after reperfusion, end of surgery</time_frame>
    <description>Stroke volume, cardiac index, systemic vasular resistance is recorded for AAD- and AOD patients at five time points during the operation using CardioQ, an oesophagus doppler monitor.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Aortic Aneurysm, Abdominal</condition>
  <condition>Aortic Diseases</condition>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Aortic aneurysm patients</arm_group_label>
    <description>10 patients with a CT verified diagnosis of aortic aneurysm demanding open elective surgical correction with insertion of vascular prosthesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aortic occlusive disease patients</arm_group_label>
    <description>10 patients with CT verified aortic occlusive disease demanding open elective surgical correction with insertion of vascular prosthesis</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine samples taken from urinary catheter. Centrifuged, supernatant frozen at -80 degrees C.&#xD;
      Immunoassay analyzed at Roche modular P quantifying NGAL.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        10 patients sceduled for elective open operation for aortic aneurysm disease and 10&#xD;
        patients sceduled for elective open operation for aortic occlusive disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CT verified aortic aneurysm or aortic occlusive disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt;18 y&#xD;
&#xD;
          -  contraindications to the use of oesophagus doppler monitor, eg mycosis, perforation,&#xD;
             stenosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lillebaelt Hospital, Kolding Hospital</name>
      <address>
        <city>Kolding</city>
        <zip>DK-6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 15, 2021</last_update_submitted>
  <last_update_submitted_qc>October 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sygehus Lillebaelt</investigator_affiliation>
    <investigator_full_name>Helene Korvenius Nedergaard</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Diseases</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</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/NCT01704391
org study id: S-20110154
nct id: NCT01704391
lead sponsor: 
has dmc: No
Open elective abdominal aortic surgery is a high risk procedure involving clamping of the
      aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD)
      causing lower limb ischaemia.

      These patients are often regarded as one entity in postoperative study settings. However,
      previous studies indicate that risk profiles, inflammatory activity, and haemodynamic
      capacity may differ between these groups. The first aim of this study was to evaluate
      postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising
      that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute
      dialysis than did patients with AOD.

      The investigators see a relatively high incidence of postoperative acute kidney injury (AKI)
      following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in
      the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of
      inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory
      response to aortic cross clamping may per se induce a rise in NGAL despite intact renal
      function. Therefore NGAL may not be a reliable marker of AKI after AAS.

      The second aim of this study is to describe the changes in NGAL after AAS in patients with
      and without postoperative dialysis-dependent AKI.
observational model: Cohort
time perspective: Prospective
measure: ICU length of stay
time frame: 24 hours postoperatively
description: Number of patients with an ICU LOS > 24 hours
measure: Post-operative need for dialysis
time frame: 72 hours postoperatively
description: Number of patients developing dialysis dependency during the first 72 hours postoperatively
measure: Hemodynamic peroperative changes in AAD vs AOD
time frame: After anaesthesia induction, 10 minutes after aortic cross-clamping, 10 minutes after reperfusion, end of surgery
description: Stroke volume, cardiac index, systemic vasular resistance is recorded for AAD- and AOD patients at five time points during the operation using CardioQ, an oesophagus doppler monitor.
arm group label: Aortic aneurysm patients
description: 10 patients with a CT verified diagnosis of aortic aneurysm demanding open elective surgical correction with insertion of vascular prosthesis
arm group label: Aortic occlusive disease patients
description: 10 patients with CT verified aortic occlusive disease demanding open elective surgical correction with insertion of vascular prosthesis
Urine samples taken from urinary catheter. Centrifuged, supernatant frozen at -80 degrees C.
      Immunoassay analyzed at Roche modular P quantifying NGAL.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Sygehus Lillebaelt
investigator full name: Helene Korvenius Nedergaard
investigator title: MD
mesh term: Acute Kidney Injury
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Diseases
mesh term: Aortic Aneurysm, Abdominal