<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/NCT03788837</url>
  </required_header>
  <id_info>
    <org_study_id>P170924J</org_study_id>
    <nct_id>NCT03788837</nct_id>
  </id_info>
  <brief_title>Ilomedin in Septic Shock With Persistent Microperfusion Defects (I-MICRO)</brief_title>
  <acronym>I-MICRO</acronym>
  <official_title>&quot; Ilomedin for Treatment of Septic Shock With Persistent Microperfusion Defects &quot;, a Double-blind, Randomized Controlled Trial:The I-MICRO 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>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>
      Septic shock remains a major cause of death in critically ill patients. Alterations in&#xD;
      microcirculation have long been proposed as a key pathophysiological factor of organ&#xD;
      dysfunction and death in septic shock patients. Persistence of mottling, prolonged skin&#xD;
      recoloration time and cyanosis of the extremities are the easily and frequently observed&#xD;
      manifestations of these microcirculatory disorders. Ilomedin is a prostaglandin analog with a&#xD;
      potent vasodilatory effect together with anti-thrombotic properties (inhibition of platelet&#xD;
      aggregation) preferentially at the microcirculatory level. An increase in cardiac output with&#xD;
      increased arterial oxygen delivery has been observed in clinical and preclinical studies with&#xD;
      no episodes of hypotension. Improvement in mesenteric perfusion has moreover been observed in&#xD;
      experimental sepsis using Ilomedin. Our group has furthermore reported that administration of&#xD;
      Ilomedin in patients with refractory septic shock (peripheral hypoperfusion) resulted in a&#xD;
      rapid and sustained improvement in peripheral perfusion. Altogether, Ilomedin may prevent or&#xD;
      improve recovery of organ dysfunction in septic shock patients through recruitment of the&#xD;
      microcirculation and, thereby, ultimately improve outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the 25 participating centers: patients with septic shock and persistent peripheral&#xD;
      hypoperfusion despite hemodynamic optimization (skin mottling and/or finger skin recoloration&#xD;
      time &gt; 3sec, and/or knee skin recoloration time &gt; 4sec), after 6 to 24 hours of&#xD;
      norepinephrine onset will be eligible for randomization.&#xD;
&#xD;
      Patients fulfilling the eligibility criteria will be included and randomized by the&#xD;
      intensivist in two groups:&#xD;
&#xD;
      *Experimental group: The patient will receive treatment with intravenous Ilomedin (blinded)&#xD;
      therapy at a dose of 0.5 ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a&#xD;
      maximum posology of 1.5ng/kg/min for 48h.&#xD;
&#xD;
      Placebo group: The patient will receive treatment with intravenous NaCl 0.9% (placebo-double&#xD;
      blinded) with increments of infusion rate every 30 minutes for 48h.&#xD;
&#xD;
      Primary outcome will be Delta Sequential Organ Failure Assessment (SOFA) score between&#xD;
      infusion onset and day 7.&#xD;
&#xD;
      *within the 12 first hours after randomization : blood samples : 15 ml of blood will be&#xD;
      collected at the same time as the sample routinely collected, within the 12 first hours after&#xD;
      randomization in ICU, when the patients are perfused.&#xD;
&#xD;
      The blood will be drawn and worked as follows:&#xD;
&#xD;
        -  2 x EDTA tubes of 5 ml : After centrifugation each tube will be directly divided into 4&#xD;
           aliquots of 500 µL (8 aliquots per patient)&#xD;
&#xD;
        -  1 x aprotinine tube of 5 ml : After centrifugation, it will be directly divided into 4&#xD;
           aliquots of 500 µL&#xD;
&#xD;
      The aliquots previously will be stored locally, and will be transported to the &quot;Centre de&#xD;
      Ressources Biologiques&quot; (CRB) of the Lariboisière Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 3, 2019</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">August 3, 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>Delta (Sequential Organ Failure Assessment (SOFA)) score between infusion onset and day 7. SOFA score assesses organ failure (respiratory, hemodynamics, liver, coagulation, neurological and kidney) in ICU patients.</measure>
    <time_frame>7 days after randomisation</time_frame>
    <description>SOFA and Delta SOFA calculation will be performed by the Intensivist. Patients deceased before day 7 will be attributed a maximum SOFA score.&#xD;
SOFA score range from 0 (no organ failure) to a maximum of 24 (worst SOFA score).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean SOFA score during the first 7 days after randomization</measure>
    <time_frame>7 days after randomization</time_frame>
    <description>SOFA and Delta SOFA calculation will be performed by the Intensivist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of survival days outside ICU in the 28 days post randomization</measure>
    <time_frame>Between ICU discharge and day 28</time_frame>
    <description>It will be calculated by the number of days between ICU discharge and day 28 in survivors of ICU stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ventilation-free survival days in the 28 days post randomization</measure>
    <time_frame>Between randomization and day 28.</time_frame>
    <description>It will be calculated as the number of survival days without mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of renal replacement therapy-free survival days in the 28 days post randomization -</measure>
    <time_frame>Between randomization and day 28.</time_frame>
    <description>It will be calculated as the number of survival days without renal replacement therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of vasopressor-free survival days in the 28 days post randomization</measure>
    <time_frame>Between randomization and day 28.</time_frame>
    <description>It will be calculated as the number of survival days without vasopressor therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Molting score at day 1 after randomization.</measure>
    <time_frame>At day 1 after randomization</time_frame>
    <description>In order to identifying and quantifying microcirculatory dysfunction in septic shock. A picture of patient's knees will be taken.&#xD;
Molting score range from 0 to a maximum of 5 :&#xD;
0. - No mottling&#xD;
- Coin sized mottling area on the knee.&#xD;
- To the superior area of the knee cap.&#xD;
- Mottling up to the middle thigh&#xD;
- Mottling up to the fold of the groin&#xD;
- Severe mottling that extends beyond the the groin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conservation of plasma for future biological measurements</measure>
    <time_frame>within 10 years after the end of the study.</time_frame>
    <description>15 ml of blood will be collected at the same time as the sample routinely collected, within the 12 first hours after randomization, when the patients are perfused.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microcirculation</measure>
    <time_frame>At the baseline, and between day 2 and day 7</time_frame>
    <description>Monitoring of microcirculation using non-invasive monitoring devices including: photoplethysmography,cutaneous Doppler coupled with iontophoresis, near-infrared spectroscopy, videomicroscopy, tissular PCO2, urethral photoplethysmography, perfusion index using phtoplethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>At day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">236</enrollment>
  <condition>Septic Shock Hyperdynamic</condition>
  <arm_group>
    <arm_group_label>intravenous Ilomedin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a first dose of Ilomedin of 0.5ng/kg/ min with increments every 30 minutes up to a maximum of 1,5 ng/kg/min for 48h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treatment with intravenous NaCl 0.9% therapy with incremental infusion rate every 30 minutes for 48h</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ilomedin</intervention_name>
    <description>The patient will receive treatment with intravenous Ilomedin therapy at a dose of 0.5ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a maximum posology of 1,5 ng/kg/min for 48h.</description>
    <arm_group_label>intravenous Ilomedin</arm_group_label>
    <other_name>50 microgrammes /0,5 ml vials</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NaCl</intervention_name>
    <description>The patient will receive treatment with intravenous NaCl 0.9% (placebo-double blinded) with increments of infusion rate every 30 minutes for 48h</description>
    <arm_group_label>Intravenous Placebo</arm_group_label>
    <other_name>(Saline 0.9%)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
          -  Signed informed consent or inclusion under the emergency provisions of the law&#xD;
             (Article L1122 -1-3 of the PHC / modified by Order n°2016-800 of June 16 2016 - art.&#xD;
             2).&#xD;
&#xD;
          -  Patients with septic shock defined by the third international definition:&#xD;
&#xD;
               -  suspected or proven infection,&#xD;
&#xD;
               -  and organ dysfunction defined by an acute change in total SOFA score &gt;or=2&#xD;
&#xD;
               -  and persistent hypotension requiring vasopressor treatment to maintain mean&#xD;
                  arterial pressure &gt; 65 mmHg despite standard of care hemodynamic optimization&#xD;
&#xD;
               -  and serum lactate level &gt; 2 mmol/L despite standard of care hemodynamic&#xD;
                  optimization&#xD;
&#xD;
               -  and persistence of peripheral hypoperfusion (skin mottling and/or finger skin&#xD;
                  recoloration time &gt; 3sec, and/or knee skin recoloration time &gt; 4sec) despite&#xD;
                  standard of care hemodynamic optimization&#xD;
&#xD;
               -  Within 6 to 24 hours after norepinephrine onset&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Pregnancy, breastfeeding&#xD;
&#xD;
          -  Hypersensitivity to Ilomedin or to any of the excipients.&#xD;
&#xD;
          -  Conditions where the hemorrhagic risk may be increased due to the effects of Ilomedin&#xD;
             on platelets (i.e., evolving hemorrhage, trauma, intracranial hemorrhage, active&#xD;
             gastric ulcer).&#xD;
&#xD;
          -  Platelet count &lt; 30000 /mm3&#xD;
&#xD;
          -  unstable angina.&#xD;
&#xD;
          -  severe cardiac rhythm disorders since Norepinephrine onset&#xD;
&#xD;
          -  severe hypoxemia (PaO2/FiO2 &lt;100)&#xD;
&#xD;
          -  myocardial infarction in the last 6 months&#xD;
&#xD;
          -  lack of Social Insurance&#xD;
&#xD;
          -  persons deprived of liberty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>François DEPRET, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP-Hôpital saint Louis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthieu LEGRAND, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>APHP-Hôpital saint Louis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>François DEPRET, MD</last_name>
    <phone>(1) 42 49 95 70</phone>
    <phone_ext>00 33</phone_ext>
    <email>francois.depret@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthieu LEGRAND, MD,PhD</last_name>
    <phone>(1) 42 49 95 70</phone>
    <phone_ext>00 33</phone_ext>
    <email>matthieu.m.legrand@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François DEPRET, MD, PhD</last_name>
      <phone>01 42 49 95 70</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>De Backer D, Donadello K. Assessment of microperfusion in sepsis. Minerva Anestesiol. 2015 May;81(5):533-40. Epub 2014 Jun 19.</citation>
    <PMID>24941897</PMID>
  </reference>
  <reference>
    <citation>Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.</citation>
    <PMID>21373821</PMID>
  </reference>
  <reference>
    <citation>Muller B, Schmidtke M. Microvascular effects of iloprost in the hamster cheek pouch. Adv Prostaglandin Thromboxane Leukot Res. 1987;17A:455-8.</citation>
    <PMID>2444080</PMID>
  </reference>
  <reference>
    <citation>Johannes T, Ince C, Klingel K, Unertl KE, Mik EG. Iloprost preserves renal oxygenation and restores kidney function in endotoxemia-related acute renal failure in the rat. Crit Care Med. 2009 Apr;37(4):1423-32. doi: 10.1097/CCM.0b013e31819b5f4e.</citation>
    <PMID>19318827</PMID>
  </reference>
  <reference>
    <citation>Hoeper MM, Gall H, Seyfarth HJ, Halank M, Ghofrani HA, Winkler J, Golpon H, Olsson KM, Nickel N, Opitz C, Ewert R. Long-term outcome with intravenous iloprost in pulmonary arterial hypertension. Eur Respir J. 2009 Jul;34(1):132-7. doi: 10.1183/09031936.00130408. Epub 2009 Feb 27.</citation>
    <PMID>19251782</PMID>
  </reference>
  <reference>
    <citation>Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.</citation>
    <PMID>29176794</PMID>
  </reference>
  <reference>
    <citation>Depret F, Sitbon A, Soussi S, De Tymowski C, Blet A, Fratani A, Legrand M. Intravenous iloprost to recruit the microcirculation in septic shock patients? Intensive Care Med. 2018 Jan;44(1):121-122. doi: 10.1007/s00134-017-4935-5. Epub 2017 Sep 18. No abstract available.</citation>
    <PMID>28921126</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>September 12, 2022</last_update_submitted>
  <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Microcirculatory defects</keyword>
  <keyword>hemodynamic macroparameters</keyword>
  <keyword>mottling</keyword>
  <keyword>Septic shock</keyword>
  <keyword>SOFA score</keyword>
  <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>
  <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/NCT03788837
org study id: P170924J
nct id: NCT03788837
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Septic shock remains a major cause of death in critically ill patients. Alterations in
      microcirculation have long been proposed as a key pathophysiological factor of organ
      dysfunction and death in septic shock patients. Persistence of mottling, prolonged skin
      recoloration time and cyanosis of the extremities are the easily and frequently observed
      manifestations of these microcirculatory disorders. Ilomedin is a prostaglandin analog with a
      potent vasodilatory effect together with anti-thrombotic properties (inhibition of platelet
      aggregation) preferentially at the microcirculatory level. An increase in cardiac output with
      increased arterial oxygen delivery has been observed in clinical and preclinical studies with
      no episodes of hypotension. Improvement in mesenteric perfusion has moreover been observed in
      experimental sepsis using Ilomedin. Our group has furthermore reported that administration of
      Ilomedin in patients with refractory septic shock (peripheral hypoperfusion) resulted in a
      rapid and sustained improvement in peripheral perfusion. Altogether, Ilomedin may prevent or
      improve recovery of organ dysfunction in septic shock patients through recruitment of the
      microcirculation and, thereby, ultimately improve outcome.
In the 25 participating centers: patients with septic shock and persistent peripheral
      hypoperfusion despite hemodynamic optimization (skin mottling and/or finger skin recoloration
      time > 3sec, and/or knee skin recoloration time > 4sec), after 6 to 24 hours of
      norepinephrine onset will be eligible for randomization.

      Patients fulfilling the eligibility criteria will be included and randomized by the
      intensivist in two groups:

      *Experimental group: The patient will receive treatment with intravenous Ilomedin (blinded)
      therapy at a dose of 0.5 ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a
      maximum posology of 1.5ng/kg/min for 48h.

      Placebo group: The patient will receive treatment with intravenous NaCl 0.9% (placebo-double
      blinded) with increments of infusion rate every 30 minutes for 48h.

      Primary outcome will be Delta Sequential Organ Failure Assessment (SOFA) score between
      infusion onset and day 7.

      *within the 12 first hours after randomization : blood samples : 15 ml of blood will be
      collected at the same time as the sample routinely collected, within the 12 first hours after
      randomization in ICU, when the patients are perfused.

      The blood will be drawn and worked as follows:

        -  2 x EDTA tubes of 5 ml : After centrifugation each tube will be directly divided into 4
           aliquots of 500 µL (8 aliquots per patient)

        -  1 x aprotinine tube of 5 ml : After centrifugation, it will be directly divided into 4
           aliquots of 500 µL

      The aliquots previously will be stored locally, and will be transported to the "Centre de
      Ressources Biologiques" (CRB) of the Lariboisière Hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Delta (Sequential Organ Failure Assessment (SOFA)) score between infusion onset and day 7. SOFA score assesses organ failure (respiratory, hemodynamics, liver, coagulation, neurological and kidney) in ICU patients.
time frame: 7 days after randomisation
description: SOFA and Delta SOFA calculation will be performed by the Intensivist. Patients deceased before day 7 will be attributed a maximum SOFA score.
SOFA score range from 0 (no organ failure) to a maximum of 24 (worst SOFA score).
measure: Mean SOFA score during the first 7 days after randomization
time frame: 7 days after randomization
description: SOFA and Delta SOFA calculation will be performed by the Intensivist.
measure: Number of survival days outside ICU in the 28 days post randomization
time frame: Between ICU discharge and day 28
description: It will be calculated by the number of days between ICU discharge and day 28 in survivors of ICU stay.
measure: Number of ventilation-free survival days in the 28 days post randomization
time frame: Between randomization and day 28.
description: It will be calculated as the number of survival days without mechanical ventilation
measure: Number of renal replacement therapy-free survival days in the 28 days post randomization -
time frame: Between randomization and day 28.
description: It will be calculated as the number of survival days without renal replacement therapy
measure: Number of vasopressor-free survival days in the 28 days post randomization
time frame: Between randomization and day 28.
description: It will be calculated as the number of survival days without vasopressor therapy
measure: Molting score at day 1 after randomization.
time frame: At day 1 after randomization
description: In order to identifying and quantifying microcirculatory dysfunction in septic shock. A picture of patient's knees will be taken.
Molting score range from 0 to a maximum of 5 :
0. - No mottling
- Coin sized mottling area on the knee.
- To the superior area of the knee cap.
- Mottling up to the middle thigh
- Mottling up to the fold of the groin
- Severe mottling that extends beyond the the groin.
measure: Conservation of plasma for future biological measurements
time frame: within 10 years after the end of the study.
description: 15 ml of blood will be collected at the same time as the sample routinely collected, within the 12 first hours after randomization, when the patients are perfused.
measure: Microcirculation
time frame: At the baseline, and between day 2 and day 7
description: Monitoring of microcirculation using non-invasive monitoring devices including: photoplethysmography,cutaneous Doppler coupled with iontophoresis, near-infrared spectroscopy, videomicroscopy, tissular PCO2, urethral photoplethysmography, perfusion index using phtoplethysmography
measure: mortality
time frame: At day 28
arm group label: intravenous Ilomedin
arm group type: Experimental
description: a first dose of Ilomedin of 0.5ng/kg/ min with increments every 30 minutes up to a maximum of 1,5 ng/kg/min for 48h
arm group label: Intravenous Placebo
arm group type: Placebo Comparator
description: Treatment with intravenous NaCl 0.9% therapy with incremental infusion rate every 30 minutes for 48h
intervention type: Drug
intervention name: Ilomedin
description: The patient will receive treatment with intravenous Ilomedin therapy at a dose of 0.5ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a maximum posology of 1,5 ng/kg/min for 48h.
arm group label: intravenous Ilomedin
other name: 50 microgrammes /0,5 ml vials
intervention type: Drug
intervention name: NaCl
description: The patient will receive treatment with intravenous NaCl 0.9% (placebo-double blinded) with increments of infusion rate every 30 minutes for 48h
arm group label: Intravenous Placebo
other name: (Saline 0.9%)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: François DEPRET, MD
role: Principal Investigator
affiliation: APHP-Hôpital saint Louis
last name: Matthieu LEGRAND, MD,PhD
role: Study Director
affiliation: APHP-Hôpital saint Louis
last name: François DEPRET, MD
phone: (1) 42 49 95 70
phone ext: 00 33
email: francois.depret@aphp.fr
last name: Matthieu LEGRAND, MD,PhD
phone: (1) 42 49 95 70
phone ext: 00 33
email: matthieu.m.legrand@gmail.com
facility: 
status: Recruiting
contact: 
country: France
citation: De Backer D, Donadello K. Assessment of microperfusion in sepsis. Minerva Anestesiol. 2015 May;81(5):533-40. Epub 2014 Jun 19.
PMID: 24941897
citation: Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.
PMID: 21373821
citation: Muller B, Schmidtke M. Microvascular effects of iloprost in the hamster cheek pouch. Adv Prostaglandin Thromboxane Leukot Res. 1987;17A:455-8.
PMID: 2444080
citation: Johannes T, Ince C, Klingel K, Unertl KE, Mik EG. Iloprost preserves renal oxygenation and restores kidney function in endotoxemia-related acute renal failure in the rat. Crit Care Med. 2009 Apr;37(4):1423-32. doi: 10.1097/CCM.0b013e31819b5f4e.
PMID: 19318827
citation: Hoeper MM, Gall H, Seyfarth HJ, Halank M, Ghofrani HA, Winkler J, Golpon H, Olsson KM, Nickel N, Opitz C, Ewert R. Long-term outcome with intravenous iloprost in pulmonary arterial hypertension. Eur Respir J. 2009 Jul;34(1):132-7. doi: 10.1183/09031936.00130408. Epub 2009 Feb 27.
PMID: 19251782
citation: Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.
PMID: 29176794
citation: Depret F, Sitbon A, Soussi S, De Tymowski C, Blet A, Fratani A, Legrand M. Intravenous iloprost to recruit the microcirculation in septic shock patients? Intensive Care Med. 2018 Jan;44(1):121-122. doi: 10.1007/s00134-017-4935-5. Epub 2017 Sep 18. No abstract available.
PMID: 28921126
responsible party type: Sponsor
mesh term: Shock, Septic
mesh term: Shock
sharing ipd: No