<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/NCT03258619</url>
  </required_header>
  <id_info>
    <org_study_id>Bouhemad-Nguyen 2016</org_study_id>
    <nct_id>NCT03258619</nct_id>
  </id_info>
  <brief_title>Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock</brief_title>
  <acronym>NARCOSE</acronym>
  <official_title>Natriuresis as a Predictor of the Haemodynamic Response to Steroid Replacement Therapy in Patients in Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of&#xD;
      cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response&#xD;
      to the ACTH stimulation test, it is recommended to systematically start steroid replacement&#xD;
      therapy with hydrocortisone hemisuccinate (HCHS) in patients in septic shock who do not&#xD;
      respond to fluid resuscitation and who continue to suffer from haemodynamic instability&#xD;
      despite increasing doses of noradrenaline.&#xD;
&#xD;
      The interest of this corticosteroid therapy lies in its ability to reduce the duration of&#xD;
      treatment with catecholamines, though the results are conflicting with regard to an eventual&#xD;
      benefit for mortality.&#xD;
&#xD;
      Steroid replacement therapy may be deleterious. It may increase the risk of sepsis and&#xD;
      secondary septic shock. It is also implicated in critical-illness polyneuropathy and blood&#xD;
      glucose dysregulation.&#xD;
&#xD;
      Today, there is no way to identify a population of patients who respond to corticosteroid&#xD;
      therapy.&#xD;
&#xD;
      From a pathophysiological viewpoint, HCHS, as well as its glucocorticoid effects, may also&#xD;
      exert mineralocorticoid effects able to compensate for the impaired renin angiotensin&#xD;
      aldosterone system (RAAS), which is responsible for the refractory aspects of septic shock.&#xD;
&#xD;
      This hyperreninism-hypoaldosteronism is found with a prevalence of around 50% of cases and is&#xD;
      defined by a plasma aldosterone/ plasma renin ratio &lt; 2. It is associated with natriuresis&#xD;
      &gt;30 mmol/l.&#xD;
&#xD;
      We hypothesise that natriuresis &gt; 30 mmol/l will make it possible to identify patients who&#xD;
      respond to steroid replacement therapy in terms of catecholamine use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Variation in doses of noradrenaline</measure>
    <time_frame>Day 3</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Septic Shock</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Aldosterone / renin dosage</intervention_name>
    <description>Plasma levels of aldosterone and renin</description>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Natriuresis</intervention_name>
    <description>natriuresis levels</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients hospitalised for septic shock&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  persons who have consented to take part&#xD;
&#xD;
          -  Patients aged 18 to 85 years&#xD;
&#xD;
          -  Admitted to an ICU for a first episode of septic shock&#xD;
&#xD;
          -  With a dose of noradrenaline ≥ 0.25µg/kg/min&#xD;
&#xD;
          -  Undergoing treatment with Hydrocortisone Hemisuccinate (HCHS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adult under guardianship&#xD;
&#xD;
          -  Patients without national health insurance cover&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Immunodepression (AIDS, corticosteroid treatment &gt; 3 weeks, Organ graft, treatment&#xD;
             with immunosuppressants)&#xD;
&#xD;
          -  Recent intake of diuretics (&lt; 6 h)&#xD;
&#xD;
          -  Long-term ACE inhibitors or ARAII&#xD;
&#xD;
          -  Chronic kidney failure (clearance &lt; 60)&#xD;
&#xD;
          -  Cirrhosis Child ≥ B&#xD;
&#xD;
          -  Chronic heart failure (NYHA III and IV)&#xD;
&#xD;
          -  Decision to limit or to stop treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bélaïd BOUHEMAD</last_name>
      <phone>0380293528</phone>
      <email>belaid.bouhemad@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</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/NCT03258619
org study id: Bouhemad-Nguyen 2016
nct id: NCT03258619
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Septic shock is responsible in 20% of cases of acute adrenal insufficiency and in 50% of
      cases of chronic 'slow' adrenal insufficiency. Given the unpredictable nature of the response
      to the ACTH stimulation test, it is recommended to systematically start steroid replacement
      therapy with hydrocortisone hemisuccinate (HCHS) in patients in septic shock who do not
      respond to fluid resuscitation and who continue to suffer from haemodynamic instability
      despite increasing doses of noradrenaline.

      The interest of this corticosteroid therapy lies in its ability to reduce the duration of
      treatment with catecholamines, though the results are conflicting with regard to an eventual
      benefit for mortality.

      Steroid replacement therapy may be deleterious. It may increase the risk of sepsis and
      secondary septic shock. It is also implicated in critical-illness polyneuropathy and blood
      glucose dysregulation.

      Today, there is no way to identify a population of patients who respond to corticosteroid
      therapy.

      From a pathophysiological viewpoint, HCHS, as well as its glucocorticoid effects, may also
      exert mineralocorticoid effects able to compensate for the impaired renin angiotensin
      aldosterone system (RAAS), which is responsible for the refractory aspects of septic shock.

      This hyperreninism-hypoaldosteronism is found with a prevalence of around 50% of cases and is
      defined by a plasma aldosterone/ plasma renin ratio < 2. It is associated with natriuresis
      >30 mmol/l.

      We hypothesise that natriuresis > 30 mmol/l will make it possible to identify patients who
      respond to steroid replacement therapy in terms of catecholamine use.
observational model: Case-Only
time perspective: Prospective
measure: Variation in doses of noradrenaline
time frame: Day 3
intervention type: Biological
intervention name: Aldosterone / renin dosage
description: Plasma levels of aldosterone and renin
intervention type: Biological
intervention name: Natriuresis
description: natriuresis levels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Shock, Septic
mesh term: Shock