<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/NCT04404400</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200018</org_study_id>
    <secondary_id>2020-003942-35</secondary_id>
    <nct_id>NCT04404400</nct_id>
  </id_info>
  <brief_title>Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency</brief_title>
  <acronym>HORNbILL</acronym>
  <official_title>Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      The study aims at assessing the efficacy and the safety of hydrocortisone combined with&#xD;
      fludrocortisone compared to placebo in ICU adults with critical illness related&#xD;
      corticosteroid insufficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothalamic-pituitary-adrenal axis together with the noradrenergic/vasopressinergic&#xD;
      system are the main systems of host response to stress. In 2008 the scientific community&#xD;
      described a syndrome called critical illness related corticosteroids insufficiency (CIRCI) in&#xD;
      which body homeostasis is lost owing to insufficient cortisol production or bioactivity in&#xD;
      tissues. Recent updates of international guidelines have spelled out the pathophysiology,&#xD;
      diagnosis and management of CIRCI. The prevalence of CIRCI varies according to case mix and&#xD;
      severity of illness. The combination of hydrocortisone and fludrocortisone improved outcomes&#xD;
      in septic shock, a condition often complicated with CIRCI. However, there is insufficient&#xD;
      evidence on the efficacy of corticosteroids in patients with CIRCI and without septic shock.&#xD;
      The hypothesis of the study is that the hydrocortisone-fludrocortisone association will&#xD;
      improve ventilation and vasopressor free survival in ICU patients with Critical illness&#xD;
      related Corticosteroid Insufficiency.&#xD;
&#xD;
      Patients with a SOFA score ≥ 4 will be screened for CIRCI. Patients suffering from CIRCI will&#xD;
      be randomized to receive hydrocortisone and fludrocortisone or their placebo. Patients&#xD;
      without CIRCI will receive standard of care and will be followed up during 90 days&#xD;
      (cohort-observational study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 17, 2022</start_date>
  <completion_date type="Anticipated">February 2026</completion_date>
  <primary_completion_date type="Anticipated">February 2026</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of ventilator- and vasopressor-free days</measure>
    <time_frame>at day 30</time_frame>
    <description>number of ventilator- and vasopressor-free days within 30 days (deaths assigned zero days) after randomisation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rates</measure>
    <time_frame>at day 30, 90 and 180</time_frame>
    <description>Mortality rates at ICU and hospital discharge and at day 30, 90 and 180 after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days alive without vasopressors</measure>
    <time_frame>at day 30</time_frame>
    <description>Number of days alive without vasopressors on day 30 after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days alive free of mechanical ventilation</measure>
    <time_frame>at day 30</time_frame>
    <description>Number of days alive free of mechanical ventilation on day 30 after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days alive with SOFA &lt; 4</measure>
    <time_frame>daily un to 30 days</time_frame>
    <description>Number of days alive with SOFA &lt; 4 in the 30 days after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Withhold and/or withdraw proportion</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Proportion of patients with a decision to withhold and/or withdraw active treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU duration</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Duration of stay (unit: day and minutes) at ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of hospitalization of stay</measure>
    <time_frame>daily up to 30 days</time_frame>
    <description>Duration of hospitalization of stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of re-admission to the ICU</measure>
    <time_frame>daily up to 30 days</time_frame>
    <description>Rate of re-admission to the ICU during the 30 days after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints - serious adverse events associated with corticosteroids</measure>
    <time_frame>daily up to 30 days</time_frame>
    <description>- Proportion of patients affected by any serious adverse events associated with corticosteroids, among the following: hospital-acquired infections, hyperglycemia, hypernatremia, neurological disorders (coma, stroke or muscle weakness) during the 30 days after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints - hospital-acquired infections proportion</measure>
    <time_frame>daily up to 30 days</time_frame>
    <description>- Proportion of patients affected by hospital-acquired infections;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints - hyperglycemia</measure>
    <time_frame>daily up to 30 days</time_frame>
    <description>- Number of episodes of hyperglycemia during ICU stay or up to day 30, whichever occurs first;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints - hypernatremia</measure>
    <time_frame>daily up to 30 days</time_frame>
    <description>- Number of episodes of hypernatremia during ICU stay or up to day 30, whichever occurs first;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints - Gastroduodenal bleeding</measure>
    <time_frame>daily up to 30 days</time_frame>
    <description>- Gastroduodenal bleeding requiring transfusion or hemostatic treatment during ICU stay or up to day 30, whichever occurs first;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints - corticosteroids administration requiring</measure>
    <time_frame>daily up to 30 days</time_frame>
    <description>- Number of patients requiring the administration corticosteroids following the end of the administration of the experimental treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of ventilation and vasopressors free survival at day 90</measure>
    <time_frame>at day 90</time_frame>
    <description>Secondary endpoint concerning screened but non-randomised patients:&#xD;
Rate of ventilation and vasopressors free survival at day 90 in subjects devoid of CIRCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal replacement therapy (RRT)-free days</measure>
    <time_frame>up to day 30</time_frame>
    <description>Renal replacement therapy (RRT)-free days up to Day 30 after randomisation (excluding patients on RRT for chronic renal failure at time of randomisation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response to glucocorticoids</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Score of cutaneous vasoconstrictor response to glucocorticoids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>up to Day 30 and 90</time_frame>
    <description>Change in utility, based on the EuroQol group's 5-dimension 5-level (EQ-5D-5L) questionnaire, up to Day 30 and 90 after randomisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of ventilation</measure>
    <time_frame>at day 30</time_frame>
    <description>Endpoint concerning non-randomised patients:&#xD;
Rate of ventilation at day 30 post SYNACTHENE® test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasopressors free days</measure>
    <time_frame>at day 30</time_frame>
    <description>Endpoint concerning non-randomised patients:&#xD;
Vasopressors free days at day 30 post SYNACTHENE® test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1092</enrollment>
  <condition>Critical Illness Related Corticosteroids Insufficiency</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For CIRCI patients: hydrocortisone + fludrocortisone therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>For CIRCI patients: hydrocortisone placebo + fludrocortisone placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Investigational products administration</intervention_name>
    <description>Investigational products include:&#xD;
Hydrocortisone hemisuccinate 50 mg: one intravenous injection every 6 hours, and&#xD;
9 alpha fludrocortisone 50 μg: one tablet per day via a nasogastric tube.&#xD;
All treatments will be stopped after 7 days or until the patient has left the intensive care unit (whichever occurs first) without tapering off.</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo administration</intervention_name>
    <description>Placebos for hydrocortisone and for fludrocortisone, administered in same manner as the active drugs in the interventional arm, for 7 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (≥ 18 years);&#xD;
&#xD;
          -  Hospitalized in an intensive care unit;&#xD;
&#xD;
          -  SOFA score ≥ 4, for at least 6 consecutive hours;&#xD;
&#xD;
          -  Informed written consent from patient or from legally authorized next of kin, or&#xD;
             emergency deferred consent;&#xD;
&#xD;
          -  Affiliation to a social security system or to a universal health coverage (Couverture&#xD;
             Maladie Universelle, CMU).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any suspected or proven acute adrenal insufficiency (As defined in international&#xD;
             guidelines; basal cortisol &lt; 5 μg/dL or peak (60) cortisol &lt;18 μg/dL)&#xD;
&#xD;
          -  Expected death or withdrawal of life-sustaining treatments within 48 hours&#xD;
&#xD;
          -  Known chronic adrenal insufficiency&#xD;
&#xD;
          -  Concomitant treatment that inhibits cortisol production&#xD;
&#xD;
          -  Septic shock (Singer Jama 2016)&#xD;
&#xD;
          -  Active tuberculosis or fungal infection&#xD;
&#xD;
          -  Active viral hepatitis or active infection with herpes viruses&#xD;
&#xD;
          -  Hypersensitivity or contraindication to hydrocortisone, fludrocortisone or Synacthène®&#xD;
             or any of their excipients ( SmPC)&#xD;
&#xD;
          -  Patient needing either anti-inflammatory corticosteroids or substitutive&#xD;
             hydrocortisone for any reason (Such as those suffering from COVID-19 pneumonia&#xD;
             requiring oxygen therapy).&#xD;
&#xD;
          -  Current treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30&#xD;
             days&#xD;
&#xD;
          -  Diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Moribund patient&#xD;
&#xD;
          -  Previously enrolled in this study&#xD;
&#xD;
          -  Participation to another interventional study that focuses on CIRCI and/or corticoid&#xD;
             drugs and/or that addresses a similar primary endpoint as Hornbill ( ventilator- and&#xD;
             vasopressor-free survival )&#xD;
&#xD;
          -  Patient under guardianship or tutorship&#xD;
&#xD;
        Note: Included patients for whom acute adrenal insufficiency would be detected in the&#xD;
        Synacthen ® test performed as part of the research for the diagnosis of CIRCI will not be&#xD;
        randomized since they should be treated by corticosteroids.&#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>Nicholas HEMING, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>General Intensive care Unit, Raymond Poincaré Hospital, APHP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Djillali ANNANE, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>General Intensive care Unit, Raymond Poincaré Hospital, APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicholas HEMING, MD, PhD</last_name>
    <phone>+ 33 1 47 10 77 78</phone>
    <email>nicholas.heming@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Djillali ANNANE, MD, PhD</last_name>
    <phone>+ 33 1 47 10 77 78</phone>
    <email>djillali.annane@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>General Intensive care Unit, Raymond Poincaré Hospital, APHP</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21. Erratum In: Intensive Care Med. 2018 Feb 23;:</citation>
    <PMID>28940011</PMID>
  </reference>
  <reference>
    <citation>Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.</citation>
    <PMID>29490185</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>critical illness related corticosteroids insufficiency</keyword>
  <keyword>hydrocortisone</keyword>
  <keyword>fludrocortisone</keyword>
  <keyword>ICU</keyword>
  <keyword>survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04404400
org study id: APHP200018
secondary id: 2020-003942-35
nct id: NCT04404400
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study aims at assessing the efficacy and the safety of hydrocortisone combined with
      fludrocortisone compared to placebo in ICU adults with critical illness related
      corticosteroid insufficiency.
The hypothalamic-pituitary-adrenal axis together with the noradrenergic/vasopressinergic
      system are the main systems of host response to stress. In 2008 the scientific community
      described a syndrome called critical illness related corticosteroids insufficiency (CIRCI) in
      which body homeostasis is lost owing to insufficient cortisol production or bioactivity in
      tissues. Recent updates of international guidelines have spelled out the pathophysiology,
      diagnosis and management of CIRCI. The prevalence of CIRCI varies according to case mix and
      severity of illness. The combination of hydrocortisone and fludrocortisone improved outcomes
      in septic shock, a condition often complicated with CIRCI. However, there is insufficient
      evidence on the efficacy of corticosteroids in patients with CIRCI and without septic shock.
      The hypothesis of the study is that the hydrocortisone-fludrocortisone association will
      improve ventilation and vasopressor free survival in ICU patients with Critical illness
      related Corticosteroid Insufficiency.

      Patients with a SOFA score ≥ 4 will be screened for CIRCI. Patients suffering from CIRCI will
      be randomized to receive hydrocortisone and fludrocortisone or their placebo. Patients
      without CIRCI will receive standard of care and will be followed up during 90 days
      (cohort-observational study).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: number of ventilator- and vasopressor-free days
time frame: at day 30
description: number of ventilator- and vasopressor-free days within 30 days (deaths assigned zero days) after randomisation.
measure: Mortality rates
time frame: at day 30, 90 and 180
description: Mortality rates at ICU and hospital discharge and at day 30, 90 and 180 after randomization
measure: Number of days alive without vasopressors
time frame: at day 30
description: Number of days alive without vasopressors on day 30 after randomization.
measure: Number of days alive free of mechanical ventilation
time frame: at day 30
description: Number of days alive free of mechanical ventilation on day 30 after randomization.
measure: Number of days alive with SOFA < 4
time frame: daily un to 30 days
description: Number of days alive with SOFA < 4 in the 30 days after randomization
measure: Withhold and/or withdraw proportion
time frame: up to 3 months
description: Proportion of patients with a decision to withhold and/or withdraw active treatments.
measure: ICU duration
time frame: up to 3 months
description: Duration of stay (unit: day and minutes) at ICU.
measure: duration of hospitalization of stay
time frame: daily up to 30 days
description: Duration of hospitalization of stay.
measure: Rate of re-admission to the ICU
time frame: daily up to 30 days
description: Rate of re-admission to the ICU during the 30 days after randomization.
measure: Safety endpoints - serious adverse events associated with corticosteroids
time frame: daily up to 30 days
description: - Proportion of patients affected by any serious adverse events associated with corticosteroids, among the following: hospital-acquired infections, hyperglycemia, hypernatremia, neurological disorders (coma, stroke or muscle weakness) during the 30 days after randomization.
measure: Safety endpoints - hospital-acquired infections proportion
time frame: daily up to 30 days
description: - Proportion of patients affected by hospital-acquired infections;
measure: Safety endpoints - hyperglycemia
time frame: daily up to 30 days
description: - Number of episodes of hyperglycemia during ICU stay or up to day 30, whichever occurs first;
measure: Safety endpoints - hypernatremia
time frame: daily up to 30 days
description: - Number of episodes of hypernatremia during ICU stay or up to day 30, whichever occurs first;
measure: Safety endpoints - Gastroduodenal bleeding
time frame: daily up to 30 days
description: - Gastroduodenal bleeding requiring transfusion or hemostatic treatment during ICU stay or up to day 30, whichever occurs first;
measure: Safety endpoints - corticosteroids administration requiring
time frame: daily up to 30 days
description: - Number of patients requiring the administration corticosteroids following the end of the administration of the experimental treatment.
measure: Rate of ventilation and vasopressors free survival at day 90
time frame: at day 90
description: Secondary endpoint concerning screened but non-randomised patients:
Rate of ventilation and vasopressors free survival at day 90 in subjects devoid of CIRCI
measure: Renal replacement therapy (RRT)-free days
time frame: up to day 30
description: Renal replacement therapy (RRT)-free days up to Day 30 after randomisation (excluding patients on RRT for chronic renal failure at time of randomisation)
measure: response to glucocorticoids
time frame: up to 3 months
description: Score of cutaneous vasoconstrictor response to glucocorticoids
measure: Change in quality of life
time frame: up to Day 30 and 90
description: Change in utility, based on the EuroQol group's 5-dimension 5-level (EQ-5D-5L) questionnaire, up to Day 30 and 90 after randomisation
measure: Rate of ventilation
time frame: at day 30
description: Endpoint concerning non-randomised patients:
Rate of ventilation at day 30 post SYNACTHENE® test
measure: Vasopressors free days
time frame: at day 30
description: Endpoint concerning non-randomised patients:
Vasopressors free days at day 30 post SYNACTHENE® test
arm group label: Active
arm group type: Experimental
description: For CIRCI patients: hydrocortisone + fludrocortisone therapy.
arm group label: Placebo
arm group type: Placebo Comparator
description: For CIRCI patients: hydrocortisone placebo + fludrocortisone placebo
intervention type: Drug
intervention name: Investigational products administration
description: Investigational products include:
Hydrocortisone hemisuccinate 50 mg: one intravenous injection every 6 hours, and
9 alpha fludrocortisone 50 μg: one tablet per day via a nasogastric tube.
All treatments will be stopped after 7 days or until the patient has left the intensive care unit (whichever occurs first) without tapering off.
arm group label: Active
intervention type: Drug
intervention name: Placebo administration
description: Placebos for hydrocortisone and for fludrocortisone, administered in same manner as the active drugs in the interventional arm, for 7 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicholas HEMING, MD, PhD
role: Principal Investigator
affiliation: General Intensive care Unit, Raymond Poincaré Hospital, APHP
last name: Djillali ANNANE, MD, PhD
role: Study Director
affiliation: General Intensive care Unit, Raymond Poincaré Hospital, APHP
last name: Nicholas HEMING, MD, PhD
phone: + 33 1 47 10 77 78
email: nicholas.heming@aphp.fr
last name: Djillali ANNANE, MD, PhD
phone: + 33 1 47 10 77 78
email: djillali.annane@aphp.fr
facility: 
status: Recruiting
country: France
citation: Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21. Erratum In: Intensive Care Med. 2018 Feb 23;:
PMID: 28940011
citation: Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.
PMID: 29490185
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No