<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/NCT04402281</url>
  </required_header>
  <id_info>
    <org_study_id>§33, HUS/141/2020 14.4.2020</org_study_id>
    <nct_id>NCT04402281</nct_id>
  </id_info>
  <brief_title>Use of suPAR Algorithm for the ED Decision Making</brief_title>
  <acronym>EDsuPAR</acronym>
  <official_title>Use of Algorithm for Safer and More Efficient Decision Making in the ED</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Will the use of a clinical decision algorithm in the ED improve discharge or admission&#xD;
      decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Crowding and readmissions are common challenges in Emergency departments across&#xD;
      Europe. The decision whether to admit or discharge the patient is challenging and is often&#xD;
      based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen&#xD;
      saturation and temperature. But some patients are unnecessarily admitted and may have been&#xD;
      better off if sent home. Other patients may be discharged without - and one out of five&#xD;
      patients are readmitted within a month raising the question whether the patient should have&#xD;
      been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker&#xD;
      measured routinely in acute medical patients in some emergency department (ED) settings.suPAR&#xD;
      is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple&#xD;
      interpretation of suPAR in clinical decisions for the study.&#xD;
&#xD;
      Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of&#xD;
      improving discharge or admission decisions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2020</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Discharges</measure>
    <time_frame>30 days</time_frame>
    <description>Number of discharges from the ED within 24 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Admissions</measure>
    <time_frame>30 days</time_frame>
    <description>Number of admissions to hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>30 days</time_frame>
    <description>Length of stay during admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>1,7 and 30 days</time_frame>
    <description>Number of readmissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Number of Mortality</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Economical savings</measure>
    <time_frame>30 days</time_frame>
    <description>Amount of money</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1800</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>suPAR algoritm control</arm_group_label>
    <description>Control arm (Meilahti hospital): Samples are collected and suPAR measured but no algorithm is implemented.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>suPAR algoritm intervention</arm_group_label>
    <description>Intervention arm (Jorvi Hospital).&#xD;
According the algorithm when admitting a patient with suPAR below 3 ng/ml, physician should answer the following question&#xD;
&quot;Are you sure it is the right decision to admit this patient? Please discuss this with a senior physician&quot;.&#xD;
If discharging a patient with suPAR above 6 ng/ml, physician should answer the following question&#xD;
&quot;Are you sure it is the right decision to discharge this patient? Please discuss this with a senior physician&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>suPAR algoritm</intervention_name>
    <description>All medical patients attending to the ED and who will have blood drawn for routine examination will be part of the study. In patients with low suPAR (green group, suPAR below 3 ng/ml) and in patients with high suPAR (red group, suPAR &gt; 6 ng/mL) the Intervention will be carried out</description>
    <arm_group_label>suPAR algoritm control</arm_group_label>
    <arm_group_label>suPAR algoritm intervention</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients during the study period who signed the consent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients above 18 years&#xD;
&#xD;
          -  who are having blood taken for biochemical analysis when attending the ED&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute medical patients that do not have blood drawn for routine biochemical testing.&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Under 18 years old&#xD;
&#xD;
          -  Terminally ill patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>104 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maaret Castrén, Docent</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Emergency Medicine and Services, Helsinki University Hospital and Helsinki University, Helsinki, Finland</name>
      <address>
        <city>Helsinki</city>
        <state>Helsinki Usimaa</state>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Marja Mäkinen</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>ED</keyword>
  <keyword>Critical illness</keyword>
  <keyword>Decision making</keyword>
  <keyword>POC test</keyword>
  <keyword>suPAR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT04402281
org study id: §33, HUS/141/2020 14.4.2020
nct id: NCT04402281
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Will the use of a clinical decision algorithm in the ED improve discharge or admission
      decisions.
Background Crowding and readmissions are common challenges in Emergency departments across
      Europe. The decision whether to admit or discharge the patient is challenging and is often
      based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen
      saturation and temperature. But some patients are unnecessarily admitted and may have been
      better off if sent home. Other patients may be discharged without - and one out of five
      patients are readmitted within a month raising the question whether the patient should have
      been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker
      measured routinely in acute medical patients in some emergency department (ED) settings.suPAR
      is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple
      interpretation of suPAR in clinical decisions for the study.

      Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of
      improving discharge or admission decisions.
observational model: Case-Control
time perspective: Other
measure: Discharges
time frame: 30 days
description: Number of discharges from the ED within 24 hours
measure: Admissions
time frame: 30 days
description: Number of admissions to hospital
measure: Length of stay
time frame: 30 days
description: Length of stay during admission
measure: Readmissions
time frame: 1,7 and 30 days
description: Number of readmissions
measure: Mortality
time frame: 30 days
description: Number of Mortality
measure: Economical savings
time frame: 30 days
description: Amount of money
arm group label: suPAR algoritm control
description: Control arm (Meilahti hospital): Samples are collected and suPAR measured but no algorithm is implemented.
arm group label: suPAR algoritm intervention
description: Intervention arm (Jorvi Hospital).
According the algorithm when admitting a patient with suPAR below 3 ng/ml, physician should answer the following question
"Are you sure it is the right decision to admit this patient? Please discuss this with a senior physician".
If discharging a patient with suPAR above 6 ng/ml, physician should answer the following question
"Are you sure it is the right decision to discharge this patient? Please discuss this with a senior physician".
intervention type: Diagnostic Test
intervention name: suPAR algoritm
description: All medical patients attending to the ED and who will have blood drawn for routine examination will be part of the study. In patients with low suPAR (green group, suPAR below 3 ng/ml) and in patients with high suPAR (red group, suPAR > 6 ng/mL) the Intervention will be carried out
arm group label: suPAR algoritm control
arm group label: suPAR algoritm intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 104 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maaret Castrén, Docent
role: Principal Investigator
affiliation: Professor
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Marja Mäkinen
investigator title: PhD
mesh term: Critical Illness
sharing ipd: No