<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/NCT02213939</url>
  </required_header>
  <id_info>
    <org_study_id>Cytosorb2014</org_study_id>
    <nct_id>NCT02213939</nct_id>
  </id_info>
  <brief_title>Clinical Impact of Cytokine in Cardiac Surgery</brief_title>
  <official_title>Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital of Cologne</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma&#xD;
      and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can&#xD;
      cause a systemic inflammatory response syndrome (SIRS) which is associated with increased&#xD;
      morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a&#xD;
      potential benefit for cardiac surgery patients.&#xD;
&#xD;
      The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with&#xD;
      the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the&#xD;
      investigators conduct this prospective, observational pilot study to determine the clinical&#xD;
      impact of the use of a cytokine adsorbing circuit during CBP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients, who have an elective myocardial revascularization and give there written consent&#xD;
      will be enrolled to the study. Demographic, intraoperative, and postoperative data will be&#xD;
      collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at&#xD;
      the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery)&#xD;
      will be analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the inflammatory response</measure>
    <time_frame>Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day</time_frame>
    <description>Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of ICU and hospital stay</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 10 days</time_frame>
    <description>Length of ICU and hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ventilation</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 10 days</time_frame>
    <description>Length of ventilation (hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of catecholamine therapy</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 10 days</time_frame>
    <description>Length of catecholamine therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kidney injury</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 10 days</time_frame>
    <description>kidney injury defined as an increase in SCr by ≥1.0 mg/dl (≥26.5 μmol/l) after surgery ; or Increase in SCr to ≥1.5 times baseline, or Urine volume &lt; 0.5 ml/kg/h for 6 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACCE (mortality; myocardial infarction; cerebrovascular accident)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 10 days</time_frame>
    <description>Mortality measured as any kind of death and myocardial death Myocardial Infarction measured with ECG; CK-MB, cTnT Cerebrovascular accident verified with abnormal cerebral CT scan</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>CPB + Cytosorb</arm_group_label>
    <description>On pump myocardial revascularization with the use of the cytokine adsorbing circuit (Cytosorb)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPB / Control</arm_group_label>
    <description>Controll group; on pump myocardial revascularization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OPCAB / Control</arm_group_label>
    <description>Controll Group; off-pump myocardial revascularization</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients receiving surgical myocardila revascularization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Elective myocardial revascularization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency procedures&#xD;
&#xD;
          -  Declined informed consent&#xD;
&#xD;
          -  Body mass index &lt; 18&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Receiving chemotherapy&#xD;
&#xD;
          -  Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia&#xD;
&#xD;
          -  Receiving antileukocyte drugs&#xD;
&#xD;
          -  Receiving TNF-α Blockers&#xD;
&#xD;
          -  Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen)&#xD;
&#xD;
          -  CRP &gt; 5 mg/dl&#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>Antje C Deppe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Cologne; Department of Cardiothoracic Surgery;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Cologne; Department of Cardiothoracic Surgery</name>
      <address>
        <city>Cologne</city>
        <zip>50379</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antje C Deppe, MD</last_name>
      <phone>0049 221 478 32453</phone>
      <email>antje-christin.deppe@uk-koeln.de</email>
    </contact>
    <contact_backup>
      <last_name>Yeong-Hoon Choi, MD</last_name>
      <phone>0049221 478 32452</phone>
      <email>yeong-hoon.choi@uk-koeln.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>July 11, 2017</last_update_submitted>
  <last_update_submitted_qc>July 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of Cologne</investigator_affiliation>
    <investigator_full_name>Dr. Antje-Christin Deppe</investigator_full_name>
    <investigator_title>MD, Resident Cardiac Surgery</investigator_title>
  </responsible_party>
  <keyword>Myocardial revascularization</keyword>
  <keyword>Cytosorb</keyword>
  <keyword>Inflammatory response</keyword>
  <keyword>Cardiopulmonary bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</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/NCT02213939
org study id: Cytosorb2014
nct id: NCT02213939
lead sponsor: 
has dmc: Yes
Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma
      and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can
      cause a systemic inflammatory response syndrome (SIRS) which is associated with increased
      morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a
      potential benefit for cardiac surgery patients.

      The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with
      the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the
      investigators conduct this prospective, observational pilot study to determine the clinical
      impact of the use of a cytokine adsorbing circuit during CBP.
Patients, who have an elective myocardial revascularization and give there written consent
      will be enrolled to the study. Demographic, intraoperative, and postoperative data will be
      collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at
      the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery)
      will be analyzed.
observational model: Case-Control
time perspective: Prospective
measure: Evolution of the inflammatory response
time frame: Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day
description: Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP
measure: Length of ICU and hospital stay
time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
description: Length of ICU and hospital stay
measure: Length of ventilation
time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
description: Length of ventilation (hours)
measure: Length of catecholamine therapy
time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
description: Length of catecholamine therapy
measure: kidney injury
time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
description: kidney injury defined as an increase in SCr by ≥1.0 mg/dl (≥26.5 μmol/l) after surgery ; or Increase in SCr to ≥1.5 times baseline, or Urine volume < 0.5 ml/kg/h for 6 hours.
measure: MACCE (mortality; myocardial infarction; cerebrovascular accident)
time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
description: Mortality measured as any kind of death and myocardial death Myocardial Infarction measured with ECG; CK-MB, cTnT Cerebrovascular accident verified with abnormal cerebral CT scan
arm group label: CPB + Cytosorb
description: On pump myocardial revascularization with the use of the cytokine adsorbing circuit (Cytosorb)
arm group label: CPB / Control
description: Controll group; on pump myocardial revascularization
arm group label: OPCAB / Control
description: Controll Group; off-pump myocardial revascularization
whole blood, serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antje C Deppe, MD
role: Principal Investigator
affiliation: University Hospital of Cologne; Department of Cardiothoracic Surgery;
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital of Cologne
investigator full name: Dr. Antje-Christin Deppe
investigator title: MD, Resident Cardiac Surgery
mesh term: Coronary Disease