<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/NCT03043170</url>
  </required_header>
  <id_info>
    <org_study_id>CardiffU</org_study_id>
    <nct_id>NCT03043170</nct_id>
  </id_info>
  <brief_title>Diagnostic Investigation and Prediction of Shock</brief_title>
  <acronym>DiPS</acronym>
  <official_title>Diagnostic Investigation and Prediction of Shock (The DiPS Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiff University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiff University</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>
      Background to the research Patients present to Emergency Departments (ED) with a spectrum of&#xD;
      illness, many of which are life- threatening. The body has the ability to compensate in the&#xD;
      early stages when things go wrong so that on the surface patients do not appear as sick as&#xD;
      they really are. Under-diagnosis of severity of illness leads to under-treatment, unnecessary&#xD;
      mortality, and unnecessary hospital costs. Earlier diagnosis and consequent treatment will&#xD;
      result in prudent healthcare, cost-benefit and better patient outcomes.&#xD;
&#xD;
      Evaluating the true underlying patient haemodynamics such as cardiac output, cardiac power&#xD;
      and peripheral pressures gives vital clues to the hidden seriousness of illness and is a&#xD;
      guide to better management. Few EDs in the world assess such haemodynamics. After evaluating&#xD;
      a haemodynamic protocol one centre in Australia was able to reduce its death rate for septic&#xD;
      shock at 30 days from 38% to 7%. We would like to evaluate whether the same would occur if&#xD;
      applied across EDs in Wales. However, before we can do that we need to strengthen our&#xD;
      understanding of haemodynamics, and of relevant protocols and non-invasive devices that help&#xD;
      us to acquire such information.&#xD;
&#xD;
      Study Design After ethics and institutional approval is obtained from we will conduct a&#xD;
      prospective, single-centre, cohort study on 354 adult patients with possible shock associated&#xD;
      with an acute illness or injury who present to the Emergency Department of the University&#xD;
      Hospital of Wales, and follow them up for 7 days. 354 is a credible number to confirm that&#xD;
      the strategy works.&#xD;
&#xD;
      Written consent will be obtained either from the patient or a relative wherever possible but&#xD;
      a waiver of consent apply to patients who, because of confusion, unconsciousness or severe&#xD;
      disability, may be unable to give consent. In these cases, consent will first be sought from&#xD;
      a second doctor and/or nurse. Thereafter, consent will be obtained from the patient or a&#xD;
      relative as soon as practically possible.&#xD;
&#xD;
      What you hope to discover&#xD;
&#xD;
      We expect to discover that:&#xD;
&#xD;
        -  Uscom variables predict 7-day survival and ICU admission&#xD;
&#xD;
        -  Uscom variables improve the detection and classification of shock&#xD;
&#xD;
        -  The LiPS definition can be improved.&#xD;
&#xD;
        -  The objective definition is better than doctors experience&#xD;
&#xD;
        -  Patients have a good experience and are satisfied with care&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients frequently present to emergency departments (EDs) with critical illness and injury.&#xD;
      Shock is a life-threatening emergency, which requires urgent and rapid assessment, diagnosis&#xD;
      and treatment, and can be classified into distributive-septic (62%), distributive-non-septic&#xD;
      (4%), hypovolaemic (16%), cardiogenic (16%) and obstructive (2%). Sepsis is the leading cause&#xD;
      of in-hospital death, and approximately 80% of these patients are admitted through the ED. In&#xD;
      Chinese patients presenting to an ED in Hong Kong we have previously derived and validated a&#xD;
      simple, a priori, pragmatic, quantitative method for recognising and classifying shock - Li's&#xD;
      Practical Shock (LiPS) tool. This method has been validated against ICU admission and early&#xD;
      mortality. However, it was derived in a single population in a single centre, and requires&#xD;
      further validation and refined in other settings. Further, it does not sub-classify patients&#xD;
      beyond 'normal, cold and warm shock', does not guide next steps in treatment, and the&#xD;
      assessment of the peripheries is very subjective.&#xD;
&#xD;
      Evaluating the true underlying patient haemodynamics such as cardiac output, cardiac power&#xD;
      and peripheral pressures gives vital clues to the hidden seriousness of illness and is a&#xD;
      guide to better management. Few EDs in the world assess such haemodynamics. After evaluating&#xD;
      a haemodynamic protocol one centre in Australia was able to reduce its death rate for septic&#xD;
      shock at 30 days from 38% to 7%. We would like to evaluate whether the same would occur if&#xD;
      applied across EDs in Wales. However, before we can do that we need to strengthen our&#xD;
      understanding of haemodynamics, and of relevant protocols and non-invasive devices that help&#xD;
      us to acquire such information.&#xD;
&#xD;
      There are many unanswered questions such as:&#xD;
&#xD;
        -  Do Uscom-derived haemodynamic variables measured in the ED predict patients who at high&#xD;
           risk of death, admission to ICU, and have shock?&#xD;
&#xD;
        -  Does a refined LiPS definition better predict mortality and ICU admission?&#xD;
&#xD;
        -  Do advanced haemodynamic predictors and/or refined LiPS predict better than experienced&#xD;
           physicians the presence and classification of patients with shock, mortality and ICU&#xD;
           admission?&#xD;
&#xD;
      This study will answer two main questions:&#xD;
&#xD;
        1. What is the probability that a patient has shock?&#xD;
&#xD;
        2. What type of shock does the patient have?&#xD;
&#xD;
      We propose:&#xD;
&#xD;
        1. To investigate whether advanced haemodynamic variables using USCOM predict 7-day&#xD;
           mortality and ICU admission.&#xD;
&#xD;
        2. To investigate whether advanced haemodynamic variables using USCOM improve the detection&#xD;
           and classification of shock.&#xD;
&#xD;
        3. To validate and refine Li's a priori Pragmatic Shock (LiPS) method for detecting and&#xD;
           classifying shock.&#xD;
&#xD;
        4. To evaluate clinical experience for shock.&#xD;
&#xD;
        5. To inform on the feasibility of future studies&#xD;
&#xD;
      After ethics and institutional approval is obtained from we will conduct a prospective,&#xD;
      single-centre, cohort study on 354 adult patients with possible shock associated with an&#xD;
      acute illness or injury who present to the Emergency Department of the University Hospital of&#xD;
      Wales, and follow them up for 7 days. 354 is a credible number to confirm that the strategy&#xD;
      works.&#xD;
&#xD;
      Written consent will be obtained either from the patient or a relative wherever possible but&#xD;
      a waiver of consent apply to patients who, because of confusion, unconsciousness or severe&#xD;
      disability, may be unable to give consent. In these cases, consent will first be sought from&#xD;
      a second doctor and/or nurse. Thereafter, consent will be obtained from the patient or a&#xD;
      relative as soon as practically possible.&#xD;
&#xD;
      The challenge is to discover a strategy that has a sensitivity &gt;67% and specificity &gt;72% for&#xD;
      determining in-hospital mortality in clinically deteriorating or potentially shocked&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>Composite of ICCU/all cause mortality</measure>
    <time_frame>7 days</time_frame>
    <description>Number of patients with admission to either ICU, or CCU, or death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Number of patients with death from any cause in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Number of patients with death from any cause within 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to ICCU</measure>
    <time_frame>7 days</time_frame>
    <description>Number of patients with admission to either ICU or CCU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ED shock</measure>
    <time_frame>Within 4 hours of ED arrival</time_frame>
    <description>Number of patients with shock in the ED defined according to LiPS criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Types of ED Shock</measure>
    <time_frame>Within 4 hours of ED arrival</time_frame>
    <description>Number of patients with ED shock categorised as either primarily restrictive or hypovolaemic, or cardiogenic or obstructive shock.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility variables</measure>
    <time_frame>4 hours</time_frame>
    <description>patient acceptance and experience, medical and nursing acceptance and experience, and evaluation of the infrastructure necessary to perform future definitive randomised controlled trials of this type in the emergency setting, to inform on sample sizes for future studies, to assess the processes and workload involved in patient recruitment, consent and reasons for non-participation, and to assess the potential loss to follow up and impact on analysis and interpretation</description>
  </other_outcome>
  <enrollment type="Actual">361</enrollment>
  <condition>Shock</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound Cardiac Output Monitor</intervention_name>
    <description>a device for assessing haemodynamics continuously and non-invasively using Doppler wave ultrasound</description>
    <other_name>USCOM®; USCOM Pty Ltd, NSW, Australia</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive adult patients presenting to the ED of University Hospital of Wales (UHW) with&#xD;
        a NEWS&gt;3, requiring a trolley, and during research study periods&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients aged ≥18 years&#xD;
&#xD;
          -  a NEWS≥3,&#xD;
&#xD;
          -  requiring a trolley&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • &lt;18 years&#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>Timothy H Rainer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Emergency Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiff University</name>
      <address>
        <city>Cardiff</city>
        <state>S Glamorgan</state>
        <zip>CF14 4XN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adults</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>Haemodynamics</keyword>
  <keyword>Resuscitation</keyword>
  <keyword>Shock</keyword>
  <keyword>Uscom</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>No plan</ipd_description>
  </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/NCT03043170
org study id: CardiffU
nct id: NCT03043170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background to the research Patients present to Emergency Departments (ED) with a spectrum of
      illness, many of which are life- threatening. The body has the ability to compensate in the
      early stages when things go wrong so that on the surface patients do not appear as sick as
      they really are. Under-diagnosis of severity of illness leads to under-treatment, unnecessary
      mortality, and unnecessary hospital costs. Earlier diagnosis and consequent treatment will
      result in prudent healthcare, cost-benefit and better patient outcomes.

      Evaluating the true underlying patient haemodynamics such as cardiac output, cardiac power
      and peripheral pressures gives vital clues to the hidden seriousness of illness and is a
      guide to better management. Few EDs in the world assess such haemodynamics. After evaluating
      a haemodynamic protocol one centre in Australia was able to reduce its death rate for septic
      shock at 30 days from 38% to 7%. We would like to evaluate whether the same would occur if
      applied across EDs in Wales. However, before we can do that we need to strengthen our
      understanding of haemodynamics, and of relevant protocols and non-invasive devices that help
      us to acquire such information.

      Study Design After ethics and institutional approval is obtained from we will conduct a
      prospective, single-centre, cohort study on 354 adult patients with possible shock associated
      with an acute illness or injury who present to the Emergency Department of the University
      Hospital of Wales, and follow them up for 7 days. 354 is a credible number to confirm that
      the strategy works.

      Written consent will be obtained either from the patient or a relative wherever possible but
      a waiver of consent apply to patients who, because of confusion, unconsciousness or severe
      disability, may be unable to give consent. In these cases, consent will first be sought from
      a second doctor and/or nurse. Thereafter, consent will be obtained from the patient or a
      relative as soon as practically possible.

      What you hope to discover

      We expect to discover that:

        -  Uscom variables predict 7-day survival and ICU admission

        -  Uscom variables improve the detection and classification of shock

        -  The LiPS definition can be improved.

        -  The objective definition is better than doctors experience

        -  Patients have a good experience and are satisfied with care
Patients frequently present to emergency departments (EDs) with critical illness and injury.
      Shock is a life-threatening emergency, which requires urgent and rapid assessment, diagnosis
      and treatment, and can be classified into distributive-septic (62%), distributive-non-septic
      (4%), hypovolaemic (16%), cardiogenic (16%) and obstructive (2%). Sepsis is the leading cause
      of in-hospital death, and approximately 80% of these patients are admitted through the ED. In
      Chinese patients presenting to an ED in Hong Kong we have previously derived and validated a
      simple, a priori, pragmatic, quantitative method for recognising and classifying shock - Li's
      Practical Shock (LiPS) tool. This method has been validated against ICU admission and early
      mortality. However, it was derived in a single population in a single centre, and requires
      further validation and refined in other settings. Further, it does not sub-classify patients
      beyond 'normal, cold and warm shock', does not guide next steps in treatment, and the
      assessment of the peripheries is very subjective.

      Evaluating the true underlying patient haemodynamics such as cardiac output, cardiac power
      and peripheral pressures gives vital clues to the hidden seriousness of illness and is a
      guide to better management. Few EDs in the world assess such haemodynamics. After evaluating
      a haemodynamic protocol one centre in Australia was able to reduce its death rate for septic
      shock at 30 days from 38% to 7%. We would like to evaluate whether the same would occur if
      applied across EDs in Wales. However, before we can do that we need to strengthen our
      understanding of haemodynamics, and of relevant protocols and non-invasive devices that help
      us to acquire such information.

      There are many unanswered questions such as:

        -  Do Uscom-derived haemodynamic variables measured in the ED predict patients who at high
           risk of death, admission to ICU, and have shock?

        -  Does a refined LiPS definition better predict mortality and ICU admission?

        -  Do advanced haemodynamic predictors and/or refined LiPS predict better than experienced
           physicians the presence and classification of patients with shock, mortality and ICU
           admission?

      This study will answer two main questions:

        1. What is the probability that a patient has shock?

        2. What type of shock does the patient have?

      We propose:

        1. To investigate whether advanced haemodynamic variables using USCOM predict 7-day
           mortality and ICU admission.

        2. To investigate whether advanced haemodynamic variables using USCOM improve the detection
           and classification of shock.

        3. To validate and refine Li's a priori Pragmatic Shock (LiPS) method for detecting and
           classifying shock.

        4. To evaluate clinical experience for shock.

        5. To inform on the feasibility of future studies

      After ethics and institutional approval is obtained from we will conduct a prospective,
      single-centre, cohort study on 354 adult patients with possible shock associated with an
      acute illness or injury who present to the Emergency Department of the University Hospital of
      Wales, and follow them up for 7 days. 354 is a credible number to confirm that the strategy
      works.

      Written consent will be obtained either from the patient or a relative wherever possible but
      a waiver of consent apply to patients who, because of confusion, unconsciousness or severe
      disability, may be unable to give consent. In these cases, consent will first be sought from
      a second doctor and/or nurse. Thereafter, consent will be obtained from the patient or a
      relative as soon as practically possible.

      The challenge is to discover a strategy that has a sensitivity >67% and specificity >72% for
      determining in-hospital mortality in clinically deteriorating or potentially shocked
      patients.
observational model: Cohort
time perspective: Prospective
measure: Composite of ICCU/all cause mortality
time frame: 7 days
description: Number of patients with admission to either ICU, or CCU, or death from any cause
measure: In-hospital mortality
time frame: 28 days
description: Number of patients with death from any cause in hospital
measure: 28-day mortality
time frame: 28 days
description: Number of patients with death from any cause within 28 days
measure: Admission to ICCU
time frame: 7 days
description: Number of patients with admission to either ICU or CCU
measure: ED shock
time frame: Within 4 hours of ED arrival
description: Number of patients with shock in the ED defined according to LiPS criteria
measure: Types of ED Shock
time frame: Within 4 hours of ED arrival
description: Number of patients with ED shock categorised as either primarily restrictive or hypovolaemic, or cardiogenic or obstructive shock.
measure: Feasibility variables
time frame: 4 hours
description: patient acceptance and experience, medical and nursing acceptance and experience, and evaluation of the infrastructure necessary to perform future definitive randomised controlled trials of this type in the emergency setting, to inform on sample sizes for future studies, to assess the processes and workload involved in patient recruitment, consent and reasons for non-participation, and to assess the potential loss to follow up and impact on analysis and interpretation
intervention type: Device
intervention name: Ultrasound Cardiac Output Monitor
description: a device for assessing haemodynamics continuously and non-invasively using Doppler wave ultrasound
other name: USCOM®; USCOM Pty Ltd, NSW, Australia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy H Rainer, MD
role: Principal Investigator
affiliation: Professor of Emergency Medicine
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Shock
sharing ipd: Undecided
ipd description: No plan