<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/NCT01670383</url>
  </required_header>
  <id_info>
    <org_study_id>SNUHEM-Repository-12-0001</org_study_id>
    <nct_id>NCT01670383</nct_id>
  </id_info>
  <brief_title>Repository for Sepsis and Postresuscitation Samples</brief_title>
  <official_title>Repository for Samples Collected From Sepsis and Postresuscitation Patients in Emergency Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to find a new therapeutic strategy by investigating the serial&#xD;
      serum samples of patients with sepsis or postresuscitation state.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2006</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>1-month mortality</measure>
    <time_frame>1 month</time_frame>
    <description>All cause mortality within 1-month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>until hospital discharge, an expected average of 2 weeks</time_frame>
    <description>All cause mortality during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Until ward transfer or discharge, an expected average of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Favorable neurologic outcome</measure>
    <time_frame>at discharge, an expected average of 2 weeks and at 6-month</time_frame>
    <description>Favorable neurologic outcome is used for outcome measure in postresuscitation patients only.&#xD;
Favorable neurologic outcome means cerebral performance category 1 and 2. This outcome is measured at discharge and 6-month after admission.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiac Arrest</condition>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Postresuscitation group</arm_group_label>
    <description>Adults (age over 16 years old) who have survived from nontraumatic cardiac arrest and admitted to ICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sepsis group</arm_group_label>
    <description>Adults (age over 16 years old) who satisfy the sepsis criteria (SIRS&gt;=2 and infection is suspected for a cause) and admitted to the ICU.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Patients sera at ICU admission, day-1, day-3 and day-7 are stored in deep freezer.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sepsis patients admitted to ICU Postresuscitation patients admitted to ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 16 years old&#xD;
&#xD;
          -  Admitted to ICU&#xD;
&#xD;
          -  Diagnosed as having sepsis or as postresuscitation status&#xD;
&#xD;
          -  Definition of sepsis: 2 or more SIRS criteria + infection is suspected&#xD;
&#xD;
          -  Definition of postresuscitation status: Survived from non-traumatic cardiac arrest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to participate&#xD;
&#xD;
          -  DNAR status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gil Joon Suh, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kyung Su Kim, MD, PhD</last_name>
    <phone>82-10-8033-1127</phone>
    <email>kanesu@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kyung Su Kim, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Kyung Su Kim, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Woon Yong Kwon, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gil Joon Suh, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.</citation>
    <PMID>11445675</PMID>
  </reference>
  <reference>
    <citation>Dombrovskiy VY, Martin AA, Sunderram J, Paz HL. Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003. Crit Care Med. 2007 May;35(5):1244-50. doi: 10.1097/01.CCM.0000261890.41311.E9.</citation>
    <PMID>17414736</PMID>
  </reference>
  <reference>
    <citation>Cohen J. The immunopathogenesis of sepsis. Nature. 2002 Dec 19-26;420(6917):885-91. doi: 10.1038/nature01326.</citation>
    <PMID>12490963</PMID>
  </reference>
  <reference>
    <citation>Schneider A, Bottiger BW, Popp E. Cerebral resuscitation after cardiocirculatory arrest. Anesth Analg. 2009 Mar;108(3):971-9. doi: 10.1213/ane.0b013e318193ca99.</citation>
    <PMID>19224811</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Gil Joon Suh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiac Arrest</keyword>
  <keyword>Sepsis</keyword>
  <keyword>Biological Markers</keyword>
  <keyword>Anti-Inflammation Agents</keyword>
  <keyword>Antioxidants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Heart Arrest</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/NCT01670383
org study id: SNUHEM-Repository-12-0001
nct id: NCT01670383
lead sponsor: 
has dmc: Yes
The objective of this study is to find a new therapeutic strategy by investigating the serial
      serum samples of patients with sepsis or postresuscitation state.
observational model: Cohort
time perspective: Prospective
measure: 1-month mortality
time frame: 1 month
description: All cause mortality within 1-month
measure: Hospital mortality
time frame: until hospital discharge, an expected average of 2 weeks
description: All cause mortality during hospitalization
measure: ICU length of stay
time frame: Until ward transfer or discharge, an expected average of 7 days
measure: Favorable neurologic outcome
time frame: at discharge, an expected average of 2 weeks and at 6-month
description: Favorable neurologic outcome is used for outcome measure in postresuscitation patients only.
Favorable neurologic outcome means cerebral performance category 1 and 2. This outcome is measured at discharge and 6-month after admission.
arm group label: Postresuscitation group
description: Adults (age over 16 years old) who have survived from nontraumatic cardiac arrest and admitted to ICU.
arm group label: Sepsis group
description: Adults (age over 16 years old) who satisfy the sepsis criteria (SIRS>=2 and infection is suspected for a cause) and admitted to the ICU.
Patients sera at ICU admission, day-1, day-3 and day-7 are stored in deep freezer.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Gil Joon Suh, Professor
role: Study Director
affiliation: Seoul National University Hospital
last name: Kyung Su Kim, MD, PhD
phone: 82-10-8033-1127
email: kanesu@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
citation: Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
PMID: 11445675
citation: Dombrovskiy VY, Martin AA, Sunderram J, Paz HL. Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003. Crit Care Med. 2007 May;35(5):1244-50. doi: 10.1097/01.CCM.0000261890.41311.E9.
PMID: 17414736
citation: Cohen J. The immunopathogenesis of sepsis. Nature. 2002 Dec 19-26;420(6917):885-91. doi: 10.1038/nature01326.
PMID: 12490963
citation: Schneider A, Bottiger BW, Popp E. Cerebral resuscitation after cardiocirculatory arrest. Anesth Analg. 2009 Mar;108(3):971-9. doi: 10.1213/ane.0b013e318193ca99.
PMID: 19224811
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Gil Joon Suh
investigator title: Professor
mesh term: Sepsis
mesh term: Toxemia
mesh term: Heart Arrest