xml: <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/NCT06020495</url>
    </required_header>
    <id_info>
      <org_study_id>APHP220676</org_study_id>
      <nct_id>NCT06020495</nct_id>
    </id_info>
    <brief_title>Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial</brief_title>
    <acronym>DASSOH</acronym>
    <official_title>Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial</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>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>
        ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multicentre, prospective, open-label randomized controlled superiority trial with&#xD;
        stratification on the presence of neurological symptoms at inclusion and on the&#xD;
        presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse,&#xD;
        malnutrition, serum potassium &lt; 3.0 mmol/L).&#xD;
  &#xD;
        Patients in ICU with severe hyponatremia defined by SNa &lt; 115 mmol/L or SNa &lt; 120 mmol/L in&#xD;
        the presence of neurological symptoms (convulsions, stupor defined by a Glasgow score &lt;12 or&#xD;
        signs of brain herniation) and a normal or decreased extracellular fluid volume will be&#xD;
        included.&#xD;
  &#xD;
        After written informed consent, they will be randomized (1:1), using a computer-generated&#xD;
        randomization scheme of various-sized blocks, stratified by the presence of neurological&#xD;
        symptoms at inclusion (seizures, stupor defined as Glasgow score &lt;12 or signs of brain&#xD;
        herniation) and on the presence/absence of risk factors for central pontine myelinolysis&#xD;
        (chronic alcohol abuse [defined according to World Health Organization definition],&#xD;
        malnutrition [BMI&lt;20.5 or weight loss &gt;5% in 3 months], serum potassium &lt; 3.0 mmol/L),&#xD;
        through a centralized 24-hour Internet service (CleanWEB™), to receive standard hyponatremic&#xD;
        treatment alone or standard hyponatremic treatment and DDAVP 4 μg/ml IV, after randomisation&#xD;
        and for a total duration of 48 hours. Since administration of DDAVP leads to an important&#xD;
        decrease in urine output and increase in urine osmolarity which are clinically obvious very&#xD;
        rapidly, a single or double blind trial is not appropriate. However, all investigators will&#xD;
        be unaware of aggregate outcomes during the study and brain MRI imaging will be performed and&#xD;
        analyzed blinded to the randomization group&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 31, 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>
      <intervention_model_description>Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium &lt; 3.0 mmol/L).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization</measure>
      <time_frame>48 hours after the randomization</time_frame>
      <description>proportion of patients with SNa level overcorrection : any risk factor: SNa increase &gt; 6 mmol/L in less than H24, or &gt;12 mmol/L in less than H48. Without risk factor: SNa increase &gt; 10 mmol/L in less than H24, or &gt; 18 mmol/L in less than H48</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion</measure>
      <time_frame>6 hours after the randomization</time_frame>
      <description>proportion of patients with neurological symptoms at inclusion and who subsequently have a normal Glasgow Coma Scale at H6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU and hospital length of stay</measure>
      <time_frame>ICU or hospital discharge</time_frame>
      <description>length of ICU and hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>survival</measure>
      <time_frame>death after randomization</time_frame>
      <description>time to death after inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria</measure>
      <time_frame>15 days after randomization</time_frame>
      <description>proportion of patients with the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria at day 15 (or earlier if clinically justified)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI</measure>
      <time_frame>15 days after randomization</time_frame>
      <description>proportion of patients with any (pontine or extrapontine), symptomatic or not, osmotic demyelination as assessed by brain MRI at day 15 (or earlier if clinically justified)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>on the percentage of patients with neurological symptoms at inclusion and reaching the initial goal of rapid partial pre-defined correction of SNa level</measure>
      <time_frame>6 hours after the randomization</time_frame>
      <description>proportion of patients with neurological symptoms with an increase of 5.0 mmol/L or more of SNa from inclusion to H6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the urine output between H0 and H6</measure>
      <time_frame>6 hours after the randomization</time_frame>
      <description>urine output between H0 and H6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the urine output between H6 and H12</measure>
      <time_frame>12 hours after the randomization</time_frame>
      <description>urine output between H6 and H12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the urine output between H12 and H24</measure>
      <time_frame>24 hours after the randomization</time_frame>
      <description>urine output between H12 and H24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the urine output between H24 and H48</measure>
      <time_frame>48 hours after the randomization</time_frame>
      <description>urine output between H24 and H48</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the urine osmolality between H0 and H6</measure>
      <time_frame>6 hours after the randomization</time_frame>
      <description>urine osmolality between H0 and H6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the urine osmolality between H6 and H12</measure>
      <time_frame>12 hours after the randomization</time_frame>
      <description>urine osmolality between H6 and H12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the urine osmolality between H12 and H24</measure>
      <time_frame>24 hours after the randomization</time_frame>
      <description>urine osmolality between H12 and H24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the urine osmolality between H24 and H48</measure>
      <time_frame>48 hours after the randomization</time_frame>
      <description>urine osmolality between H24 and H48</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SNa level correction rate between H0 and H24</measure>
      <time_frame>24 hours after the randomization</time_frame>
      <description>slope of the SNa increase between H0 and H24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SNa level correction rate between H0 and H48</measure>
      <time_frame>48 hours after the randomization</time_frame>
      <description>slope of the SNa increase between H0 and H48</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the maximal change of SNa level between H0 and H24</measure>
      <time_frame>24 hours after the randomization</time_frame>
      <description>maximum change of SNa from baseline between H0 and H24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the maximal change of SNa level between H0 and H48</measure>
      <time_frame>48 hours after the randomization</time_frame>
      <description>maximum change of SNa from baseline between H0 and H48</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>amount of hypotonic fluids administration</measure>
      <time_frame>24 hours after the randomization</time_frame>
      <description>total amount of intravenous hypotonic fluids administered between H0 and H24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>amount of hypotonic fluids administration</measure>
      <time_frame>48 hours after the randomization</time_frame>
      <description>total amount of intravenous hypotonic fluids administered between H0 and H48</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>amount of sodium and potassium administered between H0 and H24</measure>
      <time_frame>24 hours after the randomization</time_frame>
      <description>total amount of sodium and potassium administered between H0 and H24</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>amount of sodium and potassium administered between H0 and H48</measure>
      <time_frame>48 hours after the randomization</time_frame>
      <description>total amount of sodium and potassium administered between H0 and H48</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the occurrence of any new neurological sign in relation with hyponatremia in patients with a normal neurological exam at inclusion or on the reappearance of any neurological sign in relation with hyponatremia after inclusion</measure>
      <time_frame>28 days after randomization</time_frame>
      <description>proportion of patients with seizures, stupor or sign of brain herniation appearing or reappearing after inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the occurrence of excessive re-lowering of sodium</measure>
      <time_frame>48 hours after the randomization</time_frame>
      <description>Occurrence of a reduction of SNa of 5.0 mmol/L or more from inclusion between H0 and H48</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">260</enrollment>
    <condition>Hyponatremia</condition>
    <arm_group>
      <arm_group_label>DDAVP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>DDAVP 4µg/ml IV Additional doses may be administrated every 6h for a maximum of 48h&#xD;
  - Standard hyponatremia treatment : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard hyponatremia treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard hyponatremia treatment alone :&#xD;
  Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DDAVP</intervention_name>
      <description>Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)</description>
      <arm_group_label>DDAVP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Standard hyponatremia treatment</intervention_name>
      <description>Standard hyponatremia treatment alone :&#xD;
  Presence of neurological symptoms :&#xD;
  sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic</description>
      <arm_group_label>Standard hyponatremia treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults ( ≥18 years)&#xD;
  &#xD;
            -  Current admission in ICU&#xD;
  &#xD;
            -  Severe hyponatremia defined by SNa &lt;120 mmol/L in the presence of neurological&#xD;
               symptoms (seizures, stupor defined as Glasgow score &lt; 12, or signs of brain&#xD;
               herniation) or by SNa &lt;115 mmol/L&#xD;
  &#xD;
            -  Normal or decreased extracellular fluid volume&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Obvious increase of extracellular fluid volume (cirrhosis with ascites, congestive&#xD;
               heart failure, nephrotic syndrome);&#xD;
  &#xD;
            -  Previous DDAVP or hypertonic fluid administration for the current episode of severe&#xD;
               hyponatremia&#xD;
  &#xD;
            -  SNa increased by 5 mmol or more between admission at hospital and randomisation (H0)&#xD;
  &#xD;
            -  Known contraindication to DDAVP&#xD;
  &#xD;
                 -  Allergy&#xD;
  &#xD;
                 -  Syndrome of inappropriate antidiuretic hormone secretion (SIADH)&#xD;
  &#xD;
                 -  History of unstable angina and/or known or suspected heart failure.&#xD;
  &#xD;
                 -  Willebrand disease type 2b (due to risk of thrombocytopenia)&#xD;
  &#xD;
            -  Severe previous neurologic disability (Glasgow Outcome Scale &lt; 3)&#xD;
  &#xD;
            -  Diabetes insipidus receiving DDAVP treatment&#xD;
  &#xD;
            -  Moribund state (patient likely to die within 24h)&#xD;
  &#xD;
            -  Need for invasive mechanic ventilation&#xD;
  &#xD;
            -  Limitation of life support (comfort care applied only) at the time of screening&#xD;
  &#xD;
            -  Enrolment to another interventional study on hyponatremia care/management&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Subject deprived of freedom, subject under a legal protective measure&#xD;
  &#xD;
            -  No affiliation to any health insurance system&#xD;
  &#xD;
            -  Refusal to participate to the study (patient or legal representative or family member&#xD;
               or close relative if present)&#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>GAUDRY Stéphane</last_name>
      <phone>01.48.95.55.55</phone>
      <email>stephane.gaudry@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>DECHANET Aline</last_name>
      <phone>01 40 25 78 30</phone>
      <email>aline.dechanet@aphp.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</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>Hyponatremia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020495
  org study id: APHP220676
  nct id: NCT06020495
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
  Multicentre, prospective, open-label randomized controlled superiority trial with
        stratification on the presence of neurological symptoms at inclusion and on the
        presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse,
        malnutrition, serum potassium < 3.0 mmol/L).
  
        Patients in ICU with severe hyponatremia defined by SNa < 115 mmol/L or SNa < 120 mmol/L in
        the presence of neurological symptoms (convulsions, stupor defined by a Glasgow score <12 or
        signs of brain herniation) and a normal or decreased extracellular fluid volume will be
        included.
  
        After written informed consent, they will be randomized (1:1), using a computer-generated
        randomization scheme of various-sized blocks, stratified by the presence of neurological
        symptoms at inclusion (seizures, stupor defined as Glasgow score <12 or signs of brain
        herniation) and on the presence/absence of risk factors for central pontine myelinolysis
        (chronic alcohol abuse [defined according to World Health Organization definition],
        malnutrition [BMI<20.5 or weight loss >5% in 3 months], serum potassium < 3.0 mmol/L),
        through a centralized 24-hour Internet service (CleanWEB™), to receive standard hyponatremic
        treatment alone or standard hyponatremic treatment and DDAVP 4 μg/ml IV, after randomisation
        and for a total duration of 48 hours. Since administration of DDAVP leads to an important
        decrease in urine output and increase in urine osmolarity which are clinically obvious very
        rapidly, a single or double blind trial is not appropriate. However, all investigators will
        be unaware of aggregate outcomes during the study and brain MRI imaging will be performed and
        analyzed blinded to the randomization group
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium < 3.0 mmol/L).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization
  time frame: 48 hours after the randomization
  description: proportion of patients with SNa level overcorrection : any risk factor: SNa increase > 6 mmol/L in less than H24, or >12 mmol/L in less than H48. Without risk factor: SNa increase > 10 mmol/L in less than H24, or > 18 mmol/L in less than H48
  measure: the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion
  time frame: 6 hours after the randomization
  description: proportion of patients with neurological symptoms at inclusion and who subsequently have a normal Glasgow Coma Scale at H6
  measure: ICU and hospital length of stay
  time frame: ICU or hospital discharge
  description: length of ICU and hospital stay
  measure: survival
  time frame: death after randomization
  description: time to death after inclusion
  measure: the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria
  time frame: 15 days after randomization
  description: proportion of patients with the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria at day 15 (or earlier if clinically justified)
  measure: the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI
  time frame: 15 days after randomization
  description: proportion of patients with any (pontine or extrapontine), symptomatic or not, osmotic demyelination as assessed by brain MRI at day 15 (or earlier if clinically justified)
  measure: on the percentage of patients with neurological symptoms at inclusion and reaching the initial goal of rapid partial pre-defined correction of SNa level
  time frame: 6 hours after the randomization
  description: proportion of patients with neurological symptoms with an increase of 5.0 mmol/L or more of SNa from inclusion to H6
  measure: the urine output between H0 and H6
  time frame: 6 hours after the randomization
  description: urine output between H0 and H6
  measure: the urine output between H6 and H12
  time frame: 12 hours after the randomization
  description: urine output between H6 and H12
  measure: the urine output between H12 and H24
  time frame: 24 hours after the randomization
  description: urine output between H12 and H24
  measure: the urine output between H24 and H48
  time frame: 48 hours after the randomization
  description: urine output between H24 and H48
  measure: the urine osmolality between H0 and H6
  time frame: 6 hours after the randomization
  description: urine osmolality between H0 and H6
  measure: the urine osmolality between H6 and H12
  time frame: 12 hours after the randomization
  description: urine osmolality between H6 and H12
  measure: the urine osmolality between H12 and H24
  time frame: 24 hours after the randomization
  description: urine osmolality between H12 and H24
  measure: the urine osmolality between H24 and H48
  time frame: 48 hours after the randomization
  description: urine osmolality between H24 and H48
  measure: SNa level correction rate between H0 and H24
  time frame: 24 hours after the randomization
  description: slope of the SNa increase between H0 and H24
  measure: SNa level correction rate between H0 and H48
  time frame: 48 hours after the randomization
  description: slope of the SNa increase between H0 and H48
  measure: the maximal change of SNa level between H0 and H24
  time frame: 24 hours after the randomization
  description: maximum change of SNa from baseline between H0 and H24
  measure: the maximal change of SNa level between H0 and H48
  time frame: 48 hours after the randomization
  description: maximum change of SNa from baseline between H0 and H48
  measure: amount of hypotonic fluids administration
  time frame: 24 hours after the randomization
  description: total amount of intravenous hypotonic fluids administered between H0 and H24
  measure: amount of hypotonic fluids administration
  time frame: 48 hours after the randomization
  description: total amount of intravenous hypotonic fluids administered between H0 and H48
  measure: amount of sodium and potassium administered between H0 and H24
  time frame: 24 hours after the randomization
  description: total amount of sodium and potassium administered between H0 and H24
  measure: amount of sodium and potassium administered between H0 and H48
  time frame: 48 hours after the randomization
  description: total amount of sodium and potassium administered between H0 and H48
  measure: the occurrence of any new neurological sign in relation with hyponatremia in patients with a normal neurological exam at inclusion or on the reappearance of any neurological sign in relation with hyponatremia after inclusion
  time frame: 28 days after randomization
  description: proportion of patients with seizures, stupor or sign of brain herniation appearing or reappearing after inclusion
  measure: the occurrence of excessive re-lowering of sodium
  time frame: 48 hours after the randomization
  description: Occurrence of a reduction of SNa of 5.0 mmol/L or more from inclusion between H0 and H48
  arm group label: DDAVP
  arm group type: Experimental
  description: DDAVP 4µg/ml IV Additional doses may be administrated every 6h for a maximum of 48h
  - Standard hyponatremia treatment : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic
  arm group label: Standard hyponatremia treatment
  arm group type: Active Comparator
  description: Standard hyponatremia treatment alone :
  Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic
  intervention type: Drug
  intervention name: DDAVP
  description: Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)
  arm group label: DDAVP
  intervention type: Drug
  intervention name: Standard hyponatremia treatment
  description: Standard hyponatremia treatment alone :
  Presence of neurological symptoms :
  sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic
  arm group label: Standard hyponatremia treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: GAUDRY Stéphane
  phone: 01.48.95.55.55
  email: stephane.gaudry@aphp.fr
  last name: DECHANET Aline
  phone: 01 40 25 78 30
  email: aline.dechanet@aphp.fr
  responsible party type: Sponsor
  mesh term: Hyponatremia
  sharing ipd: No