<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/NCT02265419</url>
  </required_header>
  <id_info>
    <org_study_id>A 2014-0064</org_study_id>
    <nct_id>NCT02265419</nct_id>
  </id_info>
  <brief_title>Use of Extracorporeal Treatment With the Cytosorb-Adsorber for the Reduction of SIRS in Heart Surgery Patients</brief_title>
  <acronym>CASHSP</acronym>
  <official_title>Case-observation and Compassionate Use: Use of Extracorporeal Treatment With the Cytosorb-Adsorber for the Reduction of Postoperative Hyperinflammation and SIRS After Heart-surgery With the Use of a Heart-lung-machine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rostock</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rostock</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart-surgery with the use of a heart-lung-machine can trigger the development of a&#xD;
      full-blown SIRS (Systemic Inflammatory Response Syndrom) with multi organ failure and severe&#xD;
      sepsis in the course of disease.&#xD;
&#xD;
      For the treatment of full-blown SIRS extracorporeal treatment like the Cytosorb-Adsorber are&#xD;
      in clinical testing. The Cytosorb-Adsorber is a CE-signed medical device with approval for&#xD;
      the treatment of severe sepsis and hyperinflammation. The adsorber remove not-specific&#xD;
      cytokines and other inflammation mediators from the patients blood.&#xD;
&#xD;
      In this study (as a case-observation and compassionate use) the effect of extracorporeal&#xD;
      treatment with the Cytosorb-Adsorber for the reduction of postoperative hyperinflammation and&#xD;
      SIRS after heart-surgery with use of a heart-lung-machine will be observed.&#xD;
&#xD;
      The aim of the study is recording the influence of the treatment with the Cytosorb-Adsorber&#xD;
      on the course of hyperinflammation and multi organ failure in comparison with a historic&#xD;
      control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients underlying heart surgery with the use of a heart-lung-machine and fullfilling of&#xD;
      the inclusion-criteria should be sreened for the study. The study take place on two surgical&#xD;
      intensive care units (PIT I and PIT II) of the university hospital Rostock, Germany. The&#xD;
      extracorporeal treatment with the Cytosorb-Adsorber will be started 6 hours after end of the&#xD;
      operation if written informed consent was obtained from all participants or from the&#xD;
      patients' representatives if direct consent could not be received. The extracorporeal&#xD;
      treatment duration will be 24 hours and the observation time 90 days.&#xD;
&#xD;
      The aim of the study is recording the influence of the treatment with the Cytosorb-Adsorber&#xD;
      on the course of hyperinflammation and multi organ failure in comparison with a historic&#xD;
      control group. The main-criterion is a significant difference in the mean-SOFA (Sequential&#xD;
      Organ Failure Assessment)-score between the Cytosorb-group and the historic control group&#xD;
      after 7 days. Beside criterions are the 30- and 90-day survival, time of respirator-therapy,&#xD;
      length of ICU stay, severity of the Critical Illness Polyneuropathy and dosage of&#xD;
      vasopressors on the days 1, 2 and 3.&#xD;
&#xD;
      From all patients basic demographic information, illness severity (APACHE II, SOFA scores),&#xD;
      microbiological results, pre-morbidity, and clinical outcome for study cohort will recorded.&#xD;
      At the days 1-4, 7, 14, 30 and before/after the extracorporeal treatment the patients will&#xD;
      screened for clinical and immunological data: hemodynamic, inflammation, coagulation,&#xD;
      hemolysis, temperature, organ function blood parameters and cytokines. &quot;Day 1&quot; was defined as&#xD;
      the day of the beginning of the extracorporeal treatment. At days 1, 2 and 7 hemodynamic&#xD;
      monitoring will done with the PiCCO-System (PULSION Medical Systems, Feldkirchen, Germany).&#xD;
      For dynamic measurement of the liver function will used the LiMON-System (based on the&#xD;
      indocyanin green plasma disappearance rate, PULSION) on the days 1, 2 and 7.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mean SOFA</measure>
    <time_frame>day 7</time_frame>
    <description>A significant difference in the mean-SOFA (Sequential Organ Failure Assessment)-score between the Cytosorb-group and the historic control group after 7 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30- and 90-day survival</measure>
    <time_frame>day 30, day 90</time_frame>
    <description>Observation time 90 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time of respirator-therapy</measure>
    <time_frame>day 90</time_frame>
    <description>Observation time 90 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of ICU stay</measure>
    <time_frame>day 90</time_frame>
    <description>Observation time 90 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dosage of vasopressors on the days 1, 2 and 3.</measure>
    <time_frame>day 1, 2 and 3</time_frame>
    <description>Use of Vasopressors are monitored.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Multiple Organ Failure</condition>
  <arm_group>
    <arm_group_label>Cytosorb group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extracorporeal treatment with the Cytosorb adsorber for 24 hours after heart surgical operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Extracorporeal treatment with the Cytosorb adsorber</intervention_name>
    <description>The extracorporeal treatment with the Cytosorb-Adsorber will be started 6 hours after heart surgery operation, the extracorporeal treatment duration will be 24 hours and the observation time 90 days.</description>
    <arm_group_label>Cytosorb group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  After heart surgery with heart-lung-machine&#xD;
&#xD;
          -  2 or more positive SIRS criterions within 6 hours postoperative&#xD;
&#xD;
          -  need of &gt; 1,9 liter kristalloids within 6 hours postoperative&#xD;
&#xD;
          -  centralvenous oxygen saturation &gt;75% within 6 hours postoperative&#xD;
&#xD;
          -  need of vasopressors (≥0,06 µg/Kg/Min) within 6 hours postoperative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bleeding&#xD;
&#xD;
          -  Thrombocyten &lt; 20.000 /µl, INR&gt;3,0&#xD;
&#xD;
          -  HIV-Test positive&#xD;
&#xD;
          -  Hepatitis C positive&#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>Martin Sauer, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rostock, University Hospital, Intensive Care, Schillingallee 35, 18055 Rostock, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Sauer, PD Dr.</last_name>
    <phone>49 381 4946409</phone>
    <email>martin.sauer@uni-rostock.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Johannes Ehler, Dr.</last_name>
    <phone>49 381 4946401</phone>
    <email>johannes.ehler@med.uni-rostock.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Intensive Care Units PIT 1+2, University hospital Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18055</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Sauer, PD Dr.</last_name>
      <phone>49 381 4946434</phone>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>April 4, 2020</last_update_submitted>
  <last_update_submitted_qc>April 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rostock</investigator_affiliation>
    <investigator_full_name>Dr. Martin Sauer, MD</investigator_full_name>
    <investigator_title>PD Dr.</investigator_title>
  </responsible_party>
  <keyword>hyperinflammation, Cytosorb</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Organ Failure</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/NCT02265419
org study id: A 2014-0064
nct id: NCT02265419
lead sponsor: 
has dmc: Yes
Heart-surgery with the use of a heart-lung-machine can trigger the development of a
      full-blown SIRS (Systemic Inflammatory Response Syndrom) with multi organ failure and severe
      sepsis in the course of disease.

      For the treatment of full-blown SIRS extracorporeal treatment like the Cytosorb-Adsorber are
      in clinical testing. The Cytosorb-Adsorber is a CE-signed medical device with approval for
      the treatment of severe sepsis and hyperinflammation. The adsorber remove not-specific
      cytokines and other inflammation mediators from the patients blood.

      In this study (as a case-observation and compassionate use) the effect of extracorporeal
      treatment with the Cytosorb-Adsorber for the reduction of postoperative hyperinflammation and
      SIRS after heart-surgery with use of a heart-lung-machine will be observed.

      The aim of the study is recording the influence of the treatment with the Cytosorb-Adsorber
      on the course of hyperinflammation and multi organ failure in comparison with a historic
      control group.
All patients underlying heart surgery with the use of a heart-lung-machine and fullfilling of
      the inclusion-criteria should be sreened for the study. The study take place on two surgical
      intensive care units (PIT I and PIT II) of the university hospital Rostock, Germany. The
      extracorporeal treatment with the Cytosorb-Adsorber will be started 6 hours after end of the
      operation if written informed consent was obtained from all participants or from the
      patients' representatives if direct consent could not be received. The extracorporeal
      treatment duration will be 24 hours and the observation time 90 days.

      The aim of the study is recording the influence of the treatment with the Cytosorb-Adsorber
      on the course of hyperinflammation and multi organ failure in comparison with a historic
      control group. The main-criterion is a significant difference in the mean-SOFA (Sequential
      Organ Failure Assessment)-score between the Cytosorb-group and the historic control group
      after 7 days. Beside criterions are the 30- and 90-day survival, time of respirator-therapy,
      length of ICU stay, severity of the Critical Illness Polyneuropathy and dosage of
      vasopressors on the days 1, 2 and 3.

      From all patients basic demographic information, illness severity (APACHE II, SOFA scores),
      microbiological results, pre-morbidity, and clinical outcome for study cohort will recorded.
      At the days 1-4, 7, 14, 30 and before/after the extracorporeal treatment the patients will
      screened for clinical and immunological data: hemodynamic, inflammation, coagulation,
      hemolysis, temperature, organ function blood parameters and cytokines. "Day 1" was defined as
      the day of the beginning of the extracorporeal treatment. At days 1, 2 and 7 hemodynamic
      monitoring will done with the PiCCO-System (PULSION Medical Systems, Feldkirchen, Germany).
      For dynamic measurement of the liver function will used the LiMON-System (based on the
      indocyanin green plasma disappearance rate, PULSION) on the days 1, 2 and 7.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: mean SOFA
time frame: day 7
description: A significant difference in the mean-SOFA (Sequential Organ Failure Assessment)-score between the Cytosorb-group and the historic control group after 7 days.
measure: 30- and 90-day survival
time frame: day 30, day 90
description: Observation time 90 days.
measure: time of respirator-therapy
time frame: day 90
description: Observation time 90 days.
measure: length of ICU stay
time frame: day 90
description: Observation time 90 days.
measure: dosage of vasopressors on the days 1, 2 and 3.
time frame: day 1, 2 and 3
description: Use of Vasopressors are monitored.
arm group label: Cytosorb group
arm group type: Experimental
description: Extracorporeal treatment with the Cytosorb adsorber for 24 hours after heart surgical operation.
intervention type: Device
intervention name: Extracorporeal treatment with the Cytosorb adsorber
description: The extracorporeal treatment with the Cytosorb-Adsorber will be started 6 hours after heart surgery operation, the extracorporeal treatment duration will be 24 hours and the observation time 90 days.
arm group label: Cytosorb group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Sauer, PD Dr.
role: Principal Investigator
affiliation: University of Rostock, University Hospital, Intensive Care, Schillingallee 35, 18055 Rostock, Germany
last name: Martin Sauer, PD Dr.
phone: 49 381 4946409
email: martin.sauer@uni-rostock.de
last name: Johannes Ehler, Dr.
phone: 49 381 4946401
email: johannes.ehler@med.uni-rostock.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Rostock
investigator full name: Dr. Martin Sauer, MD
investigator title: PD Dr.
mesh term: Multiple Organ Failure