<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/NCT03789838</url>
  </required_header>
  <id_info>
    <org_study_id>Ulleval sepsis-01</org_study_id>
    <nct_id>NCT03789838</nct_id>
  </id_info>
  <brief_title>Effect of Sepsis Response Team in the Emergency Department</brief_title>
  <official_title>Prospective Cohort Study Examining the Effect of a Sepsis Rapid Response Team in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Does sepsis response team in the emergency department increase the portion of sepsis patient&#xD;
      who receive adequate treatment within one hour?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Does sepsis response team in the emergency department increase the portion of sepsis patient&#xD;
      who receive adequate treatment within one hour? The time from the patients arrive at the&#xD;
      emergency department to an adequate antibiotic is given, before and after introduction of a&#xD;
      sepsis response team, was registered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">May 15, 2018</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Time from arrival the emergency department to antibiotic is given.</measure>
    <time_frame>6 months</time_frame>
    <description>Time from arrival the emergency department to antibiotic is given.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">245</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Before of sepsis rapid response team</arm_group_label>
    <description>Time from arrival at the Emergency Department to antibiotic is administered, before introduction of sepsis response team in the Emergency Department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sepsis rapid response team</arm_group_label>
    <description>Time from arrival at the Emergency Department to antibiotic is administered, with sepsis response team in the Emergency Department.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sepsis rapid response team</intervention_name>
    <description>Patients with suspected sepsis is managed by a sepsis rapid response team in a structured manner.</description>
    <arm_group_label>Sepsis rapid response team</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with suspected sepsis in emergency department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with suspected sepsis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who was consider not to need antibiotics&#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>Aleksander Holten, Phd, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Trydal E, Martinsen AB, Beisland F, Jacobsen D, Holten AR. [Structured evaluation on arrival of patients with sepsis and initiation of antibiotics]. Tidsskr Nor Laegeforen. 2019 May 27;139(9). doi: 10.4045/tidsskr.18.0216. Print 2019 May 28. Norwegian.</citation>
    <PMID>31140244</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Aleksander Rygh Holten</investigator_full_name>
    <investigator_title>Consultant Physician</investigator_title>
  </responsible_party>
  <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>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03789838
org study id: Ulleval sepsis-01
nct id: NCT03789838
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Does sepsis response team in the emergency department increase the portion of sepsis patient
      who receive adequate treatment within one hour?
Does sepsis response team in the emergency department increase the portion of sepsis patient
      who receive adequate treatment within one hour? The time from the patients arrive at the
      emergency department to an adequate antibiotic is given, before and after introduction of a
      sepsis response team, was registered.
observational model: Cohort
time perspective: Prospective
measure: Time from arrival the emergency department to antibiotic is given.
time frame: 6 months
description: Time from arrival the emergency department to antibiotic is given.
arm group label: Before of sepsis rapid response team
description: Time from arrival at the Emergency Department to antibiotic is administered, before introduction of sepsis response team in the Emergency Department.
arm group label: Sepsis rapid response team
description: Time from arrival at the Emergency Department to antibiotic is administered, with sepsis response team in the Emergency Department.
intervention type: Other
intervention name: Sepsis rapid response team
description: Patients with suspected sepsis is managed by a sepsis rapid response team in a structured manner.
arm group label: Sepsis rapid response team
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aleksander Holten, Phd, MD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
citation: Trydal E, Martinsen AB, Beisland F, Jacobsen D, Holten AR. [Structured evaluation on arrival of patients with sepsis and initiation of antibiotics]. Tidsskr Nor Laegeforen. 2019 May 27;139(9). doi: 10.4045/tidsskr.18.0216. Print 2019 May 28. Norwegian.
PMID: 31140244
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Aleksander Rygh Holten
investigator title: Consultant Physician
mesh term: Sepsis
mesh term: Toxemia
mesh term: Emergencies
sharing ipd: No