<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/NCT03773822</url>
  </required_header>
  <id_info>
    <org_study_id>2018/05</org_study_id>
    <nct_id>NCT03773822</nct_id>
  </id_info>
  <brief_title>Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock.</brief_title>
  <acronym>COCCA</acronym>
  <official_title>Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CMC Ambroise Paré</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CMC Ambroise Paré</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 purpose of this randomized controlled trial is to evaluate the hemodynamic effect of low&#xD;
      dose corticosteroid therapy (hydrocortisone and fludrocortisone) in the treatment of adult&#xD;
      cardiogenic shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiogenic shock is a serious condition with a high mortality rate, characterized by acute&#xD;
      dysfunction of the heart pump. Critical illness-related corticosteroid insufficiency is a&#xD;
      pathophysiological concept, first described in septic shock. It is characterized by an&#xD;
      impairment of the hypothalamic pituitary axis during critical illness. Its diagnosis is&#xD;
      usually suggested by an inappropriate response to the adrenal stimulation test. The results&#xD;
      of corticosteroid supplementation studies in septic shock are controversial, but most of&#xD;
      these studies demonstrate that corticosteroid therapy improves reversal of shock.&#xD;
&#xD;
      The concept of critical illness-related corticosteroid insufficiency has recently been&#xD;
      expanded to cardiogenic shock. The latter has many physiopathological similarities with&#xD;
      septic shock. However, no studies have evaluated the effect of supplemental corticosteroid&#xD;
      supplementation in cardiogenic shock.&#xD;
&#xD;
      The purpose of this study is to evaluate the hemodynamic effect of low dose corticosteroid&#xD;
      therapy in the treatment of adult cardiogenic shock.&#xD;
&#xD;
      This study is a multicenter, randomized, double blinded, placebo controlled trial comparing&#xD;
      intravenous hydrocortisone (50 mg intravenously every 6 hours) plus enteral fludrocortisone&#xD;
      (50 µg/day) with placebo for seven days in critically ill patients with cardiogenic shock.&#xD;
&#xD;
      The primary endpoint for this trial will be catecholamine-fee days at day-7. Secondary&#xD;
      endpoints will include all-cause mortality at 28 and 90 days after randomisation.&#xD;
&#xD;
      Several pre-defined sub-groups analyses are planned, including: postcardiotomy, myocardial&#xD;
      infarction, etomidate use, vasopressor use...&#xD;
&#xD;
      380 patients will be enrolled in this study at approximately 20 study sites. Each patient&#xD;
      will be followed-up for 90 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 19, 2019</start_date>
  <completion_date type="Anticipated">August 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 20, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients not treated with corticosteroids at day 7</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality at 28 and 90 days after randomisation</measure>
    <time_frame>28 and 90 days after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modification of the cardiac index</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in intensive care and hospital</measure>
    <time_frame>28 and 90 days after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of support by catecholamines</measure>
    <time_frame>28 days after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance of lactatemia</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients use of mechanical ventilation</measure>
    <time_frame>28 days after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with Circulatory assistance</measure>
    <time_frame>28 days after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients alive at day 7 without failure (SOFA) score)</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with nosocomial infection</measure>
    <time_frame>28 days after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of patients requiring the introduction of intravenous insulin therapy after randomization</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modification of mean arterial pressure</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">380</enrollment>
  <condition>Cardiogenic Shock</condition>
  <arm_group>
    <arm_group_label>Placebo of hydrocortisone and placebo of fludrocortisone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of enteral fludrocortisone given once a day for seven days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination of hydrocortisone + fludrocortisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrocortisone will be given as 50 mg iv bolus every 6 hours for seven days and a tablet of 50 µg of fludrocortisone will be given once a day enterally for seven days</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Hydrocortisone + Flucortac</intervention_name>
    <description>Low dose steroids</description>
    <arm_group_label>Combination of hydrocortisone + fludrocortisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo of hydrocortisone and placebo of fludrocortisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥18 years&#xD;
&#xD;
          2. Cardiogenic shock state, according to the consensual definition:&#xD;
&#xD;
               1. Systemic arterial hypertension (systolic blood pressure &lt;90 mmHg or mean arterial&#xD;
                  pressure ≤ 65 mmHg) or signs of peripheral hypoperfusion, requiring treatment&#xD;
                  with catecholamines to maintain systolic blood pressure ≥ 90 mmHg and regression&#xD;
                  of signs of hypoperfusion;&#xD;
&#xD;
               2. Presence of at least one sign of systemic hypoperfusion among the following:&#xD;
                  marbling, oliguria ≤ 25 ml / h, impairment of consciousness, arterial&#xD;
                  hyperlactatemia&gt; 2 mmol / L;&#xD;
&#xD;
               3. Presence of at least one sign of hypocontractility or low flow among the&#xD;
                  following: cardiac index ≤ 2.2 L / min / m2, left ventricular ejection fraction&#xD;
                  (LVEF) ≤ 40% or full time velocity (ITV) under aortic ≤ 18 cm, or need for&#xD;
                  catecholamines to maintain an index&#xD;
&#xD;
               4. Clinical signs of left and / or right cardiac congestion (clinical sign of acute&#xD;
                  cardiogenic pulmonary edema or jugular turgor or edema of the lower limbs),&#xD;
                  radiological (bilateral alveolar opacities compatible with acute cardiogenic&#xD;
                  pulmonary edema), echocardiography (elevation of filling pressures of the left&#xD;
                  ventricle measured with Doppler: E / A&gt; 2 if LVEF ≤40% or E / Ea&gt; 13 if LVEF&gt;&#xD;
                  40%; or estimated PAPS&gt; 35mmHg) or with right cardiac catheterization (pulmonary&#xD;
                  artery occlusion pressures&gt; 15mmHg or PAPm&gt; 25mmHg)&#xD;
&#xD;
          3. Having received informed information about the study and having signed a consent to&#xD;
             participate in the study&#xD;
&#xD;
          4. Benefiting from a social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cardiogenic shock state with catecholamine infusion for more than 24 hours;&#xD;
&#xD;
          2. Presence Presence of septic shock at inclusion;&#xD;
&#xD;
          3. Cardiopulmonary arrest recovered in the 7 days preceding inclusion with at least one&#xD;
             early sign of poor prognosis among the following: no control, non-shockable rhythm,&#xD;
             CAHP score (Cardiac Arrest Hospital Prognosis)&gt; 150;&#xD;
&#xD;
          4. Patients already on circulatory support (ECMO) before inclusion (patients who are&#xD;
             assisted after inclusion will not be excluded);&#xD;
&#xD;
          5. Cardiogenic shock on viral myocarditis;&#xD;
&#xD;
          6. Prior corticosteroid therapy (≥ 30 mg prednisone or equivalent ≥ 1 month);&#xD;
&#xD;
          7. Receiving one of the following treatments: ketoconazole, rifampicin, phenytoin,&#xD;
             phenobarbital, cyclosporine and clarithromycin;&#xD;
&#xD;
          8. Known history of hypersensitivity to fludrocortisone or hydrocortisone;&#xD;
&#xD;
          9. Known pregnancy or breastfeeding;&#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_contact>
    <last_name>Armand MEKONTSO DESSAP, MD</last_name>
    <phone>(+33)1 46 25 24 33</phone>
    <email>armand.dessap@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>François BAGATE,, MD</last_name>
    <phone>(+33)1 49 81 23 89</phone>
    <email>francois.bagate@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Paris</city>
        <state>Ile De France</state>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Armand MEKONTSO DESSAP, MD</last_name>
    </contact>
    <investigator>
      <last_name>Armand MEKONTSO DESSAP, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>François BAGATE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Parly II</name>
      <address>
        <city>Le Chesnay</city>
        <state>Le Chasnay</state>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH Intercommunal de Villeneuve Saint Georges</name>
      <address>
        <city>Villeneuve-Saint-Georges</city>
        <state>Villeneuve Saint Georges</state>
        <zip>94190</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Ambroise Paré</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH de Marne la Vallée - Site Jossigny</name>
      <address>
        <city>Jossigny</city>
        <zip>77600</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Lille - Institut Cœur Poumon</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Saint Joseph Saint Luc</name>
      <address>
        <city>Lyon</city>
        <zip>69007</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé Jacques Cartier</name>
      <address>
        <city>Massy</city>
        <zip>91300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Arnaud-de-Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <zip>34090</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CMC Ambroise Paré</name>
      <address>
        <city>Neuilly sur seine</city>
        <zip>92200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre SQUARA, MD</last_name>
      <phone>0146415079</phone>
      <email>recherche@clinique-a-pare.fr</email>
    </contact>
    <contact_backup>
      <last_name>Messaouda MERZOUG, PhD</last_name>
      <email>recherche@clinique-a-pare.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Pierre SQUARA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe ESTAGNASIE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alain BRUSSET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Driss LAGHLEM, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nîmes</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital européen Georges-Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH Pontoise</name>
      <address>
        <city>Pontoise</city>
        <zip>95300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre cardiologique du nord saint denis</name>
      <address>
        <city>Saint-Denis</city>
        <zip>93200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tristan MORICHAU-BEAUCHANT, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Hopital Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clément DELMAS, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU Hôpitaux de Tours</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiogenic Shock</keyword>
  <keyword>Steroids</keyword>
  <keyword>Hydrocortisone</keyword>
  <keyword>Fludrocortisone</keyword>
  <keyword>Reversal of shock</keyword>
  <keyword>Mortality</keyword>
  <keyword>Adrenal insufficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Cardiogenic</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03773822
org study id: 2018/05
nct id: NCT03773822
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized controlled trial is to evaluate the hemodynamic effect of low
      dose corticosteroid therapy (hydrocortisone and fludrocortisone) in the treatment of adult
      cardiogenic shock.
Cardiogenic shock is a serious condition with a high mortality rate, characterized by acute
      dysfunction of the heart pump. Critical illness-related corticosteroid insufficiency is a
      pathophysiological concept, first described in septic shock. It is characterized by an
      impairment of the hypothalamic pituitary axis during critical illness. Its diagnosis is
      usually suggested by an inappropriate response to the adrenal stimulation test. The results
      of corticosteroid supplementation studies in septic shock are controversial, but most of
      these studies demonstrate that corticosteroid therapy improves reversal of shock.

      The concept of critical illness-related corticosteroid insufficiency has recently been
      expanded to cardiogenic shock. The latter has many physiopathological similarities with
      septic shock. However, no studies have evaluated the effect of supplemental corticosteroid
      supplementation in cardiogenic shock.

      The purpose of this study is to evaluate the hemodynamic effect of low dose corticosteroid
      therapy in the treatment of adult cardiogenic shock.

      This study is a multicenter, randomized, double blinded, placebo controlled trial comparing
      intravenous hydrocortisone (50 mg intravenously every 6 hours) plus enteral fludrocortisone
      (50 µg/day) with placebo for seven days in critically ill patients with cardiogenic shock.

      The primary endpoint for this trial will be catecholamine-fee days at day-7. Secondary
      endpoints will include all-cause mortality at 28 and 90 days after randomisation.

      Several pre-defined sub-groups analyses are planned, including: postcardiotomy, myocardial
      infarction, etomidate use, vasopressor use...

      380 patients will be enrolled in this study at approximately 20 study sites. Each patient
      will be followed-up for 90 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Patients not treated with corticosteroids at day 7
time frame: 7 days
measure: Mortality at 28 and 90 days after randomisation
time frame: 28 and 90 days after randomisation
measure: Modification of the cardiac index
time frame: 7 days
measure: Length of stay in intensive care and hospital
time frame: 28 and 90 days after randomisation
measure: Duration of support by catecholamines
time frame: 28 days after randomisation
measure: Clearance of lactatemia
time frame: 7 days
measure: Number of patients use of mechanical ventilation
time frame: 28 days after randomisation
measure: Number of patients with Circulatory assistance
time frame: 28 days after randomisation
measure: Number of patients alive at day 7 without failure (SOFA) score)
time frame: 7 days
measure: Rate of patients with nosocomial infection
time frame: 28 days after randomisation
measure: Rates of patients requiring the introduction of intravenous insulin therapy after randomization
time frame: 7 days
measure: Modification of mean arterial pressure
time frame: 7 days
arm group label: Placebo of hydrocortisone and placebo of fludrocortisone
arm group type: Placebo Comparator
description: Placebo of hydrocortisone as an iv bolus every 6 hours for seven days plus placebo of enteral fludrocortisone given once a day for seven days
arm group label: Combination of hydrocortisone + fludrocortisone
arm group type: Experimental
description: Hydrocortisone will be given as 50 mg iv bolus every 6 hours for seven days and a tablet of 50 µg of fludrocortisone will be given once a day enterally for seven days
intervention type: Combination Product
intervention name: Hydrocortisone + Flucortac
description: Low dose steroids
arm group label: Combination of hydrocortisone + fludrocortisone
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo of hydrocortisone and placebo of fludrocortisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Armand MEKONTSO DESSAP, MD
phone: (+33)1 46 25 24 33
email: armand.dessap@aphp.fr
last name: François BAGATE,, MD
phone: (+33)1 49 81 23 89
email: francois.bagate@aphp.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Shock, Cardiogenic
mesh term: Shock
mesh term: Hydrocortisone
sharing ipd: Undecided