<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/NCT04422782</url>
  </required_header>
  <id_info>
    <org_study_id>PrediDengue</org_study_id>
    <nct_id>NCT04422782</nct_id>
  </id_info>
  <brief_title>New Tools for Predicting Capillary Leak Shock During Dengue Fever</brief_title>
  <acronym>PrediDengue</acronym>
  <official_title>New Tools for Predicting Capillary Leak Shock During Dengue Fever</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier de Cayenne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Regional Development Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier de Cayenne</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluate the prognostic value of different methods (Osmometry / clinical-biological score)&#xD;
      compared to the occurrence of capillary leak shock during dengue fever.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On the South American continent, dengue fever progressively progresses to hyperendemia with&#xD;
      co-circulation of different serotypes. Among the complications of dengue fever, a frequent&#xD;
      complication is the shock linked to capillary leakage which often occurs at the time of&#xD;
      defervescence between the 3rd or 5th day of evolution of the fever. Before that, it is&#xD;
      difficult to identify patients who are at risk for severe forms. Patients are therefore seen&#xD;
      regularly to monitor for the development of serious forms, which causes saturation of the&#xD;
      health system. Despite everything, with each epidemic, the investigators observe deaths of&#xD;
      previously healthy people, which always constitutes an important trauma for the population&#xD;
      and for the carers. Improving the understanding of the pathophysiology of capillary leakage&#xD;
      and the tools to predict it would be significant advances in this common tropical pathology.&#xD;
      Thus a retrospective study of longitudinal data during the dengue 2 epidemic of 2013 made it&#xD;
      possible to generate precise hypotheses as to the pathophysiology of the shock linked to&#xD;
      capillary leakage. Hypoprotidemia and hyponatremia having a strong statistical association&#xD;
      with the subsequent occurrence of shock, the hypothesis is of a progressive disturbance of&#xD;
      the plasma osmolarity resulting in water leaks towards the interstitial sector.&#xD;
&#xD;
      These preliminary data also made it possible to develop a predictive score which must now be&#xD;
      validated over time.&#xD;
&#xD;
      Research involving the human person, monocentric, prospective, validation&#xD;
&#xD;
      Interventional research protocol involving the human person category 2 at risk and minimal&#xD;
      constraints&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 14, 2020</start_date>
  <completion_date type="Anticipated">May 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 14, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of a shock</measure>
    <time_frame>2 years</time_frame>
    <description>The primary outcome measure will be the occurrence of a shock defined by systolic blood pressure &lt;90 mm Hg in adults and &lt;80 mm Hg in children.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictive value of plasma hypo-osmolarity</measure>
    <time_frame>2 years</time_frame>
    <description>Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validation of the clinical-biological prognostic score</measure>
    <time_frame>2 years</time_frame>
    <description>Prospectively validate the clinical-biological prognostic score (2013 shock score) and, if possible, improve it</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between the measurements obtained by osmolarity and capillary leakage</measure>
    <time_frame>2 years</time_frame>
    <description>Study the relationship between the measurements obtained by osmolarity and capillary leakage measured by pleural effusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage</measure>
    <time_frame>2 years</time_frame>
    <description>Evaluation of the sensitivity / specificity and predictive values of these measures in relation to the ultrasound objectification of a pleural effusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution</measure>
    <time_frame>2 years</time_frame>
    <description>Specify how long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the factor &quot;Presence of sickle cell disease&quot; and &quot;occurrence of severe dengue&quot;</measure>
    <time_frame>2 years</time_frame>
    <description>Study the association between the factor &quot;Presence of sickle cell disease&quot; and &quot;occurrence of severe dengue&quot;</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">342</enrollment>
  <condition>Dengue Fever</condition>
  <condition>Children</condition>
  <condition>Adults</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single Arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine</intervention_name>
    <description>Interventional research protocol involving the human person category 2 at risk and minimal constraints</description>
    <arm_group_label>Single Arm</arm_group_label>
    <other_name>Collection of biological samples : Aliquot of remnants of urine and blood for possible ancillary studies on prognostic factors for occurrence of shock due to capillary leakage during dengue</other_name>
    <other_name>Systematic search for effusion done in a standardized manner with 3 ultrasound incidences: longitudinal medio axillary, longitudinal medio clavicular and transverse views of the right upper quadrant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; = 5 years&#xD;
&#xD;
          -  Patient / parent consent&#xD;
&#xD;
          -  Exclude other pathology with capillary circulation problem (septic shock, anaphylaxis)&#xD;
             All suspected dengue fever requiring hospitalization will be included, final inclusion&#xD;
             being after biological confirmation (AgNS1, RT-PCR, serology).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;5 years&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Unsigned consent&#xD;
&#xD;
          -  Coinfection by another agent&#xD;
&#xD;
          -  Patient under guardianship or curatorship.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mathieu NACHER, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier de Cayenne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Felix DJOSSOU, MD</last_name>
    <phone>0594395040</phone>
    <phone_ext>+594</phone_ext>
    <email>felix.djossou@ch-cayenne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>DRISP General Hospital of Cayenne</last_name>
    <phone>0594395385</phone>
    <phone_ext>+594</phone_ext>
    <email>cicec@ch-cayenne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>General Hospital of Cayenne</name>
      <address>
        <city>Cayenne</city>
        <state>French Guiana</state>
        <zip>97306</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathieu Nacher, MD, PhD</last_name>
      <phone>0594395024</phone>
      <phone_ext>5024</phone_ext>
      <email>mathieu.nacher@ch-cayenne.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Djossou F, Vesin G, Elenga N, Demar M, Epelboin L, Walter G, Abboud P, Le-Guen T, Rousset D, Moreau B, Mahamat A, Malvy D, Nacher M. A predictive score for hypotension in patients with confirmed dengue fever in Cayenne Hospital, French Guiana. Trans R Soc Trop Med Hyg. 2016 Dec 1;110(12):705-713. doi: 10.1093/trstmh/trx004.</citation>
    <PMID>28938048</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 9, 2020</last_update_submitted>
  <last_update_submitted_qc>December 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dengue</keyword>
  <keyword>Dengue fever</keyword>
  <keyword>Children</keyword>
  <keyword>Adults</keyword>
  <keyword>French Guiana</keyword>
  <keyword>Hypovolemic shock</keyword>
  <keyword>Osmolarity</keyword>
  <keyword>Hyponatremia</keyword>
  <keyword>Hypoprotidemia</keyword>
  <keyword>Clinical-biological score</keyword>
  <keyword>Interstitial fluid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dengue</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <!-- 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/NCT04422782
org study id: PrediDengue
nct id: NCT04422782
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluate the prognostic value of different methods (Osmometry / clinical-biological score)
      compared to the occurrence of capillary leak shock during dengue fever.
On the South American continent, dengue fever progressively progresses to hyperendemia with
      co-circulation of different serotypes. Among the complications of dengue fever, a frequent
      complication is the shock linked to capillary leakage which often occurs at the time of
      defervescence between the 3rd or 5th day of evolution of the fever. Before that, it is
      difficult to identify patients who are at risk for severe forms. Patients are therefore seen
      regularly to monitor for the development of serious forms, which causes saturation of the
      health system. Despite everything, with each epidemic, the investigators observe deaths of
      previously healthy people, which always constitutes an important trauma for the population
      and for the carers. Improving the understanding of the pathophysiology of capillary leakage
      and the tools to predict it would be significant advances in this common tropical pathology.
      Thus a retrospective study of longitudinal data during the dengue 2 epidemic of 2013 made it
      possible to generate precise hypotheses as to the pathophysiology of the shock linked to
      capillary leakage. Hypoprotidemia and hyponatremia having a strong statistical association
      with the subsequent occurrence of shock, the hypothesis is of a progressive disturbance of
      the plasma osmolarity resulting in water leaks towards the interstitial sector.

      These preliminary data also made it possible to develop a predictive score which must now be
      validated over time.

      Research involving the human person, monocentric, prospective, validation

      Interventional research protocol involving the human person category 2 at risk and minimal
      constraints
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Occurrence of a shock
time frame: 2 years
description: The primary outcome measure will be the occurrence of a shock defined by systolic blood pressure <90 mm Hg in adults and <80 mm Hg in children.
measure: Predictive value of plasma hypo-osmolarity
time frame: 2 years
description: Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue
measure: Validation of the clinical-biological prognostic score
time frame: 2 years
description: Prospectively validate the clinical-biological prognostic score (2013 shock score) and, if possible, improve it
measure: Relationship between the measurements obtained by osmolarity and capillary leakage
time frame: 2 years
description: Study the relationship between the measurements obtained by osmolarity and capillary leakage measured by pleural effusion
measure: Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage
time frame: 2 years
description: Evaluation of the sensitivity / specificity and predictive values of these measures in relation to the ultrasound objectification of a pleural effusion
measure: How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution
time frame: 2 years
description: Specify how long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution
measure: Association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
time frame: 2 years
description: Study the association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
arm group label: Single Arm
arm group type: Other
description: Single Arm
intervention type: Other
intervention name: For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine
description: Interventional research protocol involving the human person category 2 at risk and minimal constraints
arm group label: Single Arm
other name: Collection of biological samples : Aliquot of remnants of urine and blood for possible ancillary studies on prognostic factors for occurrence of shock due to capillary leakage during dengue
other name: Systematic search for effusion done in a standardized manner with 3 ultrasound incidences: longitudinal medio axillary, longitudinal medio clavicular and transverse views of the right upper quadrant
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Mathieu NACHER, MD, PhD
role: Study Director
affiliation: Centre Hospitalier de Cayenne
last name: Felix DJOSSOU, MD
phone: 0594395040
phone ext: +594
email: felix.djossou@ch-cayenne.fr
last name: DRISP General Hospital of Cayenne
phone: 0594395385
phone ext: +594
email: cicec@ch-cayenne.fr
facility: 
status: Recruiting
contact: 
country: France
citation: Djossou F, Vesin G, Elenga N, Demar M, Epelboin L, Walter G, Abboud P, Le-Guen T, Rousset D, Moreau B, Mahamat A, Malvy D, Nacher M. A predictive score for hypotension in patients with confirmed dengue fever in Cayenne Hospital, French Guiana. Trans R Soc Trop Med Hyg. 2016 Dec 1;110(12):705-713. doi: 10.1093/trstmh/trx004.
PMID: 28938048
responsible party type: Sponsor
mesh term: Dengue
mesh term: Fever