<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/NCT03752047</url>
  </required_header>
  <id_info>
    <org_study_id>PMD-CS-006ii</org_study_id>
    <nct_id>NCT03752047</nct_id>
  </id_info>
  <brief_title>Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients</brief_title>
  <official_title>Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PMD Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital of South West Jutland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PMD Solutions</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>
      The primary objective is to determine if the trend in Respiratory Rate measurements provided&#xD;
      by the device under investigation can be used to predict an increase in&#xD;
      Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.&#xD;
&#xD;
      The RR trend will be measured as the difference between the RR recorded by the device at a&#xD;
      point 15 minutes after commencement of treatment, as per the standard of care for patients&#xD;
      suspected of being septic, and a point 3 hours following this.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to determine if the trend in Respiratory Rate measurements provided&#xD;
      by the device under investigation can be used to predict an increase in&#xD;
      Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.&#xD;
&#xD;
      The RR trend will be measured as the difference between the RR recorded by the device at a&#xD;
      point 15 minutes after commencement of treatment, as per the standard of care for patients&#xD;
      suspected of being septic, and a point 3 hours following this.&#xD;
&#xD;
      Secondary objective The secondary objective is to test if Respiratory Rate can help identify&#xD;
      patients at increased risk of 30 day mortality.&#xD;
&#xD;
      The null Hypotheses of the planned comparison is that there is no difference in the RR trend&#xD;
      in the 3 hours following commencement of treatment for sepsis in subjects who have an&#xD;
      increase in SOFA score by 2 or more points and those who have a change in SOFA score of +1 or&#xD;
      less.&#xD;
&#xD;
      The change in SOFA score will be measured at point of commencement of treatment and at 6&#xD;
      hours following commencement of treatment, or nearest available SOFA score determination.&#xD;
&#xD;
      Respiratory Rate captured during admission could have a predictive course for cohort of&#xD;
      interest&#xD;
&#xD;
      The time points for reviewing the RR will be as follows:&#xD;
&#xD;
      (i) The last measurement (ii) The trend over 3 hours following commencement of treatment as&#xD;
      per the standard of care for patients suspected of being septic.&#xD;
&#xD;
      (iii) The trend over the entire duration of admission&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2017</start_date>
  <completion_date type="Actual">November 21, 2017</completion_date>
  <primary_completion_date type="Actual">September 9, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>RespiraSense triggered escalation in SOFA score</measure>
    <time_frame>15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.</time_frame>
    <description>Escalation of SOFA score by 2 or more points. The primary endpoint will be evaluated with an ANCOVA with escalation of SOFA score by 2 or more points as a factor and mean RR in the first hour of treatment as a covariate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Upward trend in Respiratory Rate as a predictor of 30 day mortality</measure>
    <time_frame>30 days after discharge</time_frame>
    <description>The secondary endpoint is the 30 day mortality rate after discharge.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Upward trend in Respiratory Rate as a predictor of 30 day readmission.</measure>
    <time_frame>30 days after discharge</time_frame>
    <description>The secondary endpoint is the 30 day readmission rate after discharge.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">132</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Suspicion of Sepsis</arm_group_label>
    <description>Patients who are admitted and are diagnosed with sepsis will be recruited for this investigation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        For this investigation, the population of interest are patients admitted to the Acute&#xD;
        Medical Unit (AMU) with sepsis or that develop sepsis during their admission.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  ≥ 18 Years&#xD;
&#xD;
          -  Admitted for a minimum of 12 hours&#xD;
&#xD;
          -  Have been diagnosed with sepsis&#xD;
&#xD;
        Sepsis diagnosis confirmed by documented or suspected infection (ordering of blood culture&#xD;
        or other microbiological investigation by the clinician) and ≥1 of the following presenting&#xD;
        within the first 4 hours of admission:&#xD;
&#xD;
          -  Fever or hypothermia, Core temperature &gt; 38.3 or &lt; 36 °C&#xD;
&#xD;
          -  Heart rate &gt; 90/min&#xD;
&#xD;
          -  Respiratory rate &gt; 20/min&#xD;
&#xD;
          -  Altered consciousness/mental state, defined as GCS &lt; 15&#xD;
&#xD;
          -  Hyperglycemia, (BS &gt; 6.7 mmol/L non-diabetic)&#xD;
&#xD;
          -  LKC &gt; 12 *10^9 or &lt; 4*10^9,&#xD;
&#xD;
          -  Normal LKC with &gt; 10 % immature cells,&#xD;
&#xD;
          -  CRP &gt; highest normal local lab. Interval&#xD;
&#xD;
          -  Hypotension: Systolic BP &lt;90 mmHg, or drop in systolic BP &gt; 40&#xD;
&#xD;
          -  Hypoxemia: PaO2 &lt; 8.5 Kpa or PaO2/FiO2 &lt; 40 or tissue perfusion: P-lactate &gt; 1.6&#xD;
&#xD;
          -  Creatinine . 177 µmol/L&#xD;
&#xD;
          -  Acute oliguria (Diuresis per hour ,0.5 ml/kg/t or 45 ml/t in 2 hours)&#xD;
&#xD;
          -  Coagulopathy: Spontaneous INR &gt; 1.5, or apt &gt; 60 sec, thrombocytopenia&#xD;
&#xD;
          -  Paralytic ileus (absence of bowel sounds)&#xD;
&#xD;
          -  Hyperbilirubinemia &gt; 34µmol/L&#xD;
&#xD;
          -  Are willing to voluntarily sign a statement of informed consent to participate in this&#xD;
             investigation&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Allergic to medical grade skin adhesive&#xD;
&#xD;
          -  Pregnant women during second and third trimester&#xD;
&#xD;
          -  Continuous long term steroid use. Defined as not using steroids in the 4 weeks&#xD;
             previous to enrolment&#xD;
&#xD;
          -  Patients under the influence of substance abuse (drug or alcohol) that may interfere&#xD;
             with their ability to cooperate and comply with the investigation procedures&#xD;
&#xD;
          -  Any disorder, including cognitive dysfunction, which would affect the ability to&#xD;
             accurately complete questionnaires and freely give full informed consent. This will be&#xD;
             determined by the Abbreviated Mental Test Score (AMT) Cannot be followed a second time&#xD;
             if admitted again at a later date during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hospital of South West Jutland, Department of Emergency Medicine</name>
      <address>
        <city>Esbjerg</city>
        <state>South West Jutland</state>
        <zip>DK-6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data can be shared upon request.</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/NCT03752047
org study id: PMD-CS-006ii
nct id: NCT03752047
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to determine if the trend in Respiratory Rate measurements provided
      by the device under investigation can be used to predict an increase in
      Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.

      The RR trend will be measured as the difference between the RR recorded by the device at a
      point 15 minutes after commencement of treatment, as per the standard of care for patients
      suspected of being septic, and a point 3 hours following this.
The primary objective is to determine if the trend in Respiratory Rate measurements provided
      by the device under investigation can be used to predict an increase in
      Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.

      The RR trend will be measured as the difference between the RR recorded by the device at a
      point 15 minutes after commencement of treatment, as per the standard of care for patients
      suspected of being septic, and a point 3 hours following this.

      Secondary objective The secondary objective is to test if Respiratory Rate can help identify
      patients at increased risk of 30 day mortality.

      The null Hypotheses of the planned comparison is that there is no difference in the RR trend
      in the 3 hours following commencement of treatment for sepsis in subjects who have an
      increase in SOFA score by 2 or more points and those who have a change in SOFA score of +1 or
      less.

      The change in SOFA score will be measured at point of commencement of treatment and at 6
      hours following commencement of treatment, or nearest available SOFA score determination.

      Respiratory Rate captured during admission could have a predictive course for cohort of
      interest

      The time points for reviewing the RR will be as follows:

      (i) The last measurement (ii) The trend over 3 hours following commencement of treatment as
      per the standard of care for patients suspected of being septic.

      (iii) The trend over the entire duration of admission
observational model: Cohort
time perspective: Retrospective
measure: RespiraSense triggered escalation in SOFA score
time frame: 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
description: Escalation of SOFA score by 2 or more points. The primary endpoint will be evaluated with an ANCOVA with escalation of SOFA score by 2 or more points as a factor and mean RR in the first hour of treatment as a covariate.
measure: Upward trend in Respiratory Rate as a predictor of 30 day mortality
time frame: 30 days after discharge
description: The secondary endpoint is the 30 day mortality rate after discharge.
measure: Upward trend in Respiratory Rate as a predictor of 30 day readmission.
time frame: 30 days after discharge
description: The secondary endpoint is the 30 day readmission rate after discharge.
arm group label: Suspicion of Sepsis
description: Patients who are admitted and are diagnosed with sepsis will be recruited for this investigation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Denmark
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: Data can be shared upon request.