<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/NCT04502511</url>
  </required_header>
  <id_info>
    <org_study_id>202000405</org_study_id>
    <nct_id>NCT04502511</nct_id>
  </id_info>
  <brief_title>Heterogeneity of Critical Illness: a Cohort Study</brief_title>
  <acronym>HEALICS</acronym>
  <official_title>Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</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>
      Rationale: There is large heterogeneity in disease states of critically ill patients at ICU&#xD;
      admittance and there is also large heterogeneity in their disease severity during ICU stay.&#xD;
      Still, some patients may show remarkable similarities in disease patterns. There is a lack of&#xD;
      understanding of causal mechanisms that lead to divergent outcomes in critically ill&#xD;
      patients, and at the same time different diseases may share common underlying, yet&#xD;
      unidentified, causal pathways that could explain similarities between different diseases.&#xD;
&#xD;
      Objective: To explore the association between patient characteristics and the severity of&#xD;
      organ failure in critically ill patients admitted to the ICU Study design: Prospective cohort&#xD;
      study Study population: Adult critically ill patients in the ICU Intervention (if&#xD;
      applicable): not applicable Main study parameters/endpoints: Maximum severity of organ&#xD;
      failure observed during ICU stay measured by the maximum SOFA score and quality of life at&#xD;
      one year follow-up&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: &lt;All patients will undergo physical examination, including ultrasound evaluation&#xD;
      upon ICU admission according to standard practice care. The burden will be a blood sample&#xD;
      (and urine sample) at admission. Blood sample will be obtained by arterial line (or venous&#xD;
      access) which is part of standard ICU care. So there will be no additional puncture for this&#xD;
      study. Collection of variables during ICU stay will all be either part of standard clinical&#xD;
      care or include extra physical examination or ultrasound evaluation. For follow-up patients&#xD;
      will be evaluated by phone at 6 months and at 12 months by home-visit. This is also already&#xD;
      part of the investigator's evaluation of quality of care. Except for blood sampling, all&#xD;
      study related procedures have previously been approved by the Institutional Review Board&#xD;
      (IRB). The patient will experience no individual benefit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2023</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>Severity of organ failure observed during ICU stay</measure>
    <time_frame>During ICU admission with a maximum of 90 days</time_frame>
    <description>The primary prognostic outcome will be the maximum SOFA score during ICU stay. The daily maximum SOFA score will be considered up to a maximum of 90 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Follow-up Quality of life data</measure>
    <time_frame>6 and 12 months after ICU discharge</time_frame>
    <description>Patients will be evaluated by questionnaires at 6 and 12 months follow-up.Follow-up data will include survival status and data on quality of life.&#xD;
Patients psychological functioning will be evaluated using the Short Form 20 and the Hospital Anxiety and Depression Scale (HADS).&#xD;
Patients physical functioning data will be measured by the KATZ ADL index and the Clinical Frailty Score. In addition, the Euro-Qol (EQ-5d) will be used.&#xD;
Social functioning data will be collected using the General Functioning 6 scale (GF6) which is a subscale of the GF12 and is a quick and effective tool to assess the overall functioning of families. Data will be collected from both patients and family members. Return to work will only be evaluated at 12 months follow-up by 4 extra questions concerning the patients return to work.&#xD;
In addition we will explore and validate extended modifications on the total and domain level of the organ failure assessment score (SOFA+).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Critically Ill</condition>
  <condition>Organ Failure, Multiple</condition>
  <arm_group>
    <arm_group_label>Adult critically ill patients in the ICU</arm_group_label>
    <description>Acutely admitted to the ICU</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard diagnosis test</intervention_name>
    <description>Care as usual</description>
    <arm_group_label>Adult critically ill patients in the ICU</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients acutely admitted to the ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults Definition: age ≥18 years.&#xD;
&#xD;
          -  Emergency admission to the ICU Definition: patients who are acutely admitted to the&#xD;
             ICU due to acute or unexpected critical illness, either from the emergency department&#xD;
             or the ward or transferred from an ICU (or a ward) from another hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned admission&#xD;
&#xD;
          -  Absence of an invasive arterial or venous line for blood sampling.&#xD;
&#xD;
          -  Any continued cardiopulmonary resuscitation efforts upon admission which limit access&#xD;
             to the patient for research activities.&#xD;
&#xD;
          -  Main ICU admission reason chronic (non-invasive) home ventilation&#xD;
&#xD;
          -  Main ICU admission reason normothermic treatment after cardiac arrest&#xD;
&#xD;
          -  Main ICU admission reason ischemic stroke, intracerebral bleeding, or isolated&#xD;
             neurotrauma&#xD;
&#xD;
          -  Main ICU admission reason Coronavirus Disease 2019 (COVID-19)&#xD;
&#xD;
          -  Solid organ or hematopoietic stem cell transplant during current hospital admission&#xD;
&#xD;
          -  Strict isolation due to any contagious disease&#xD;
&#xD;
          -  No informed consent&#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>Frederik Keus, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Willem Dieperink, PhD</last_name>
    <phone>+31 503619838</phone>
    <email>w.dieperink@umcg.nl</email>
  </overall_contact>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Frederik Keus</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Multiple Organ Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>On request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>In two years</ipd_time_frame>
    <ipd_access_criteria>On request</ipd_access_criteria>
  </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/NCT04502511
org study id: 202000405
nct id: NCT04502511
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: There is large heterogeneity in disease states of critically ill patients at ICU
      admittance and there is also large heterogeneity in their disease severity during ICU stay.
      Still, some patients may show remarkable similarities in disease patterns. There is a lack of
      understanding of causal mechanisms that lead to divergent outcomes in critically ill
      patients, and at the same time different diseases may share common underlying, yet
      unidentified, causal pathways that could explain similarities between different diseases.

      Objective: To explore the association between patient characteristics and the severity of
      organ failure in critically ill patients admitted to the ICU Study design: Prospective cohort
      study Study population: Adult critically ill patients in the ICU Intervention (if
      applicable): not applicable Main study parameters/endpoints: Maximum severity of organ
      failure observed during ICU stay measured by the maximum SOFA score and quality of life at
      one year follow-up
Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: <All patients will undergo physical examination, including ultrasound evaluation
      upon ICU admission according to standard practice care. The burden will be a blood sample
      (and urine sample) at admission. Blood sample will be obtained by arterial line (or venous
      access) which is part of standard ICU care. So there will be no additional puncture for this
      study. Collection of variables during ICU stay will all be either part of standard clinical
      care or include extra physical examination or ultrasound evaluation. For follow-up patients
      will be evaluated by phone at 6 months and at 12 months by home-visit. This is also already
      part of the investigator's evaluation of quality of care. Except for blood sampling, all
      study related procedures have previously been approved by the Institutional Review Board
      (IRB). The patient will experience no individual benefit.
observational model: Cohort
time perspective: Prospective
measure: Severity of organ failure observed during ICU stay
time frame: During ICU admission with a maximum of 90 days
description: The primary prognostic outcome will be the maximum SOFA score during ICU stay. The daily maximum SOFA score will be considered up to a maximum of 90 days.
measure: Follow-up Quality of life data
time frame: 6 and 12 months after ICU discharge
description: Patients will be evaluated by questionnaires at 6 and 12 months follow-up.Follow-up data will include survival status and data on quality of life.
Patients psychological functioning will be evaluated using the Short Form 20 and the Hospital Anxiety and Depression Scale (HADS).
Patients physical functioning data will be measured by the KATZ ADL index and the Clinical Frailty Score. In addition, the Euro-Qol (EQ-5d) will be used.
Social functioning data will be collected using the General Functioning 6 scale (GF6) which is a subscale of the GF12 and is a quick and effective tool to assess the overall functioning of families. Data will be collected from both patients and family members. Return to work will only be evaluated at 12 months follow-up by 4 extra questions concerning the patients return to work.
In addition we will explore and validate extended modifications on the total and domain level of the organ failure assessment score (SOFA+).
arm group label: Adult critically ill patients in the ICU
description: Acutely admitted to the ICU
intervention type: Diagnostic Test
intervention name: Standard diagnosis test
description: Care as usual
arm group label: Adult critically ill patients in the ICU
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederik Keus, PhD
role: Principal Investigator
affiliation: University Medical Center Groningen
last name: Willem Dieperink, PhD
phone: +31 503619838
email: w.dieperink@umcg.nl
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Frederik Keus
investigator title: Principal investigator
mesh term: Critical Illness
mesh term: Multiple Organ Failure
sharing ipd: Yes
ipd description: On request
ipd info type: Study Protocol
ipd time frame: In two years
ipd access criteria: On request