<?xml version="1.0" encoding="UTF-8"?>
<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    http://clinicaltrials.gov/ct2/html/images/info/public.xsd
 and an XML DTD at:
    http://clinicaltrials.gov/ct2/html/images/info/public.dtd -->
  <required_header>
    <download_date>Information obtained from ClinicalTrials.gov on May 16, 2013</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>http://clinicaltrials.gov/show/NCT00998140</url>
  </required_header>
  <id_info>
    <org_study_id>NIHPR 08/90/a</org_study_id>
    <nct_id>NCT00998140</nct_id>
  </id_info>
  <brief_title>Optimizing Resuscitation After Cardiac Arrest in the Community</brief_title>
  <official_title>Optimizing Resuscitation After Cardiac Arrest in the Community: Increasing the Probability of Survival While Reducing Costs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaare Zedek Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaare Zedek Medical Center</source>
  <oversight_info>
    <authority>Israel: Ministry of Health</authority>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Resuscitative efforts have been shown to be unsuccessful in most cases of out-of-hospital
      cardiac arrest (OHCA), and survivors who do recover cardiac function often sustain severe
      hypoxic brain damage.  Time to efficacious care is a primary determinant of disability-free
      survival.  In the Jerusalem district, only 9% of OHCA patients present with ventricular
      tachycardia/ventricular fibrillation (VT/VF) as the primary rhythm, whereas 77% present with
      asystole; this seems primarily to be the result of long collapse-to-arrival times.
      Nevertheless, overly zealous resuscitation is undertaken in a high proportion of arrests
      with a futile prognosis, leading to excessive costs.

      Study hypotheses:

        1. Subpopulations for whom intervention is futile/counter-productive are identifiable

        2. Substantial waste of resources can be avoided

        3. Optimization of emergency medical services (EMS) reorganization without adding
           resources is an achievable goal
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Anticipated">March 2012</completion_date>
  <phase>N/A</phase>
  <study_type>Observational</study_type>
  <study_design>Observational Model:  Cohort</study_design>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>Cardiopulmonary Arrest Outcome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the
        absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem
        district.
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:

          -  All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the
             absence of either spontaneous respiration or palpable pulse or both) within the
             Jerusalem district.

        Exclusion Criteria:

          -  Patients with do-not-resuscitate orders or an advance directive to that effect.
      </textblock>
    </criteria>
    <gender>Both</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Einav, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaare Zedek Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sharon Einav, MD</last_name>
    <phone>972-508-685-480</phone>
    <email>einav_s@szmc.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nechama Kaufman, MN</last_name>
    <phone>972-508-685-324</phone>
    <email>kaufman_n@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sharon Einav, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2011</verification_date>
  <lastchanged_date>May 17, 2011</lastchanged_date>
  <firstreceived_date>October 18, 2009</firstreceived_date>
  <responsible_party>
    <name_title>Sharon Einav, MD, Director of Surgical ICU</name_title>
    <organization>Shaare Zedek Medical Center</organization>
  </responsible_party>
  <keyword>resuscitation</keyword>
  <keyword>sudden death</keyword>
  <keyword>cardiopulmonary resuscitation</keyword>
  <keyword>emergency medical services</keyword>
  <keyword>termination of resuscitation</keyword>
  <keyword>ventricular fibrillation</keyword>
  <keyword>out-of-hospital cardiac arrest</keyword>
  <keyword>asystole</keyword>
  <keyword>medical futility</keyword>
  <keyword>withdrawing treatment</keyword>
  <keyword>transportation of patients</keyword>
  <keyword>health expenditures</keyword>
  <keyword>healthcare costs</keyword>
  <is_fda_regulated>No</is_fda_regulated>
  <has_expanded_access>No</has_expanded_access>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm  -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                -->
</clinical_study>
