<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/NCT03831685</url>
  </required_header>
  <id_info>
    <org_study_id>LAPHSUS study</org_study_id>
    <nct_id>NCT03831685</nct_id>
  </id_info>
  <brief_title>Blood Lactate Level for Pre-hospital Orientation of Septic Shock</brief_title>
  <acronym>LAPHSUS</acronym>
  <official_title>Contribution of Pre-hospital Blood Lactate Level for Pre-hospital Orientation of Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Necker-Enfants Malades</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fire Brigade Of Paris Emergency Medicine Dept</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hôpital Necker-Enfants Malades</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>
      In the pre-hospital setting, the severity assessment of septic shock is essential to decide&#xD;
      the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a&#xD;
      need for an additional element in order to enhance the severity assessment and to decide&#xD;
      in-hospital admission in the intensive care unit (ICU) or in the emergency department (ED).&#xD;
      Point of care medical device yielding blood lactate levels since the pre-hospital setting may&#xD;
      give an easy and valuable element for the severity assessment and the decision-making.&#xD;
&#xD;
      The aim of this study is to provide clinical evidence that the pre-hospital blood lactate&#xD;
      level predicts the 30-day mortality of patients with septic shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective, observational, non-randomized controlled study. A total of 1000&#xD;
      patients requiring mobile intensive care unit intervention for a septic shock in the&#xD;
      pre-hospital setting will be included. Pre-hospital blood lactate levels will not be taken&#xD;
      into account to decide patients treatments and/or ED or ICU admission. In the pre-hospital&#xD;
      setting, each patient will benefit from 2 measurements of blood lactate level: initial&#xD;
      measurement at the first contact, and final measurement at the hospital admission with a&#xD;
      specific point of care medical device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality after inclusion</measure>
    <time_frame>30 days</time_frame>
    <description>mortality rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit length of stay</measure>
    <time_frame>90 days</time_frame>
    <description>Duration of ICU length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>90 days</time_frame>
    <description>Duration of Hospital length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilatory support</measure>
    <time_frame>30 days</time_frame>
    <description>Duration of mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic support</measure>
    <time_frame>30 days</time_frame>
    <description>Duration of catecholamines' infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hemodiaflitration</measure>
    <time_frame>30 days</time_frame>
    <description>Duration of extra renal support</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Sepsis</condition>
  <condition>Lactate Blood Increase</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Patients meeting the inclusion criteria and none of the non-inclusion criteria will benefit from 2 venous blood samples in order to precise the initial blood lactate level, e.g. at the first medical contact, and the final blood lactate level, e.g. at the hospital admission.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Venous blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit&#xD;
        intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years either sex&#xD;
&#xD;
          -  Severe sepsis according to the French anesthesiology and intensive care society (SFAR)&#xD;
             and intensive care society (SRLF) conference 2005 defined by the existence of an&#xD;
             infectious disease and at least one the following:&#xD;
&#xD;
               -  Low blood pressure prior to volume expansion&#xD;
&#xD;
               -  Glasgow coma scale &lt; 13&#xD;
&#xD;
               -  Skin mottling score &gt; 2&#xD;
&#xD;
          -  Septic shock according to the French anesthesiology and intensive care society (SFAR)&#xD;
             and intensive care society (SRLF) conference 2005 definition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Serious comorbid conditions with a not to be reanimated status known since&#xD;
             pre-hospital setting&#xD;
&#xD;
          -  Patients with guardianship or curator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romain Jouffroy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Romain Jouffroy, MD</last_name>
    <phone>+33144495989</phone>
    <email>romain.jouffroy@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Benoit Vivien, MD, PhD</last_name>
    <phone>+3314492424</phone>
    <email>benoit.vivien@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>APHP Necker Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain Jouffroy, MD</last_name>
      <phone>+3314495989</phone>
      <email>romain.jouffroy@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Benoit Vivien, MD, PhD</last_name>
      <phone>+33144492424</phone>
      <email>benoit.vivien@aphp.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Jean Pierre Tourtier, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guillaume Debaty, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vincent Bounes, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Papa Gueye Ngalgou, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Marecaux G, Pinsky MR, Dupont E, Kahn RJ, Vincent JL. Blood lactate levels are better prognostic indicators than TNF and IL-6 levels in patients with septic shock. Intensive Care Med. 1996 May;22(5):404-8. doi: 10.1007/BF01712155.</citation>
    <PMID>8796390</PMID>
  </reference>
  <reference>
    <citation>Bakker J, Coffernils M, Leon M, Gris P, Vincent JL. Blood lactate levels are superior to oxygen-derived variables in predicting outcome in human septic shock. Chest. 1991 Apr;99(4):956-62. doi: 10.1378/chest.99.4.956.</citation>
    <PMID>2009802</PMID>
  </reference>
  <reference>
    <citation>Cicarelli DD, Vieira JE, Bensenor FE. [Lactate as a predictor of mortality and multiple organ failure in patients with the systemic inflammatory response syndrome.]. Rev Bras Anestesiol. 2007 Dec;57(6):630-8. doi: 10.1590/s0034-70942007000600005. Portuguese.</citation>
    <PMID>19462139</PMID>
  </reference>
  <reference>
    <citation>Gaieski DF, Goyal M. Serum lactate as a predictor of mortality in emergency department patients with infection: does the lactate level tell the whole story? Ann Emerg Med. 2005 Dec;46(6):561-2; author reply 562. doi: 10.1016/j.annemergmed.2005.07.021. No abstract available.</citation>
    <PMID>16308078</PMID>
  </reference>
  <reference>
    <citation>Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.</citation>
    <PMID>19325467</PMID>
  </reference>
  <reference>
    <citation>Shapiro NI, Howell MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, Weiss JW. Serum lactate as a predictor of mortality in emergency department patients with infection. Ann Emerg Med. 2005 May;45(5):524-8. doi: 10.1016/j.annemergmed.2004.12.006.</citation>
    <PMID>15855951</PMID>
  </reference>
  <reference>
    <citation>Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, Parrillo JE, Dellinger RP, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009 Jul;32(1):35-9. doi: 10.1097/shk.0b013e3181971d47.</citation>
    <PMID>19533847</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Necker-Enfants Malades</investigator_affiliation>
    <investigator_full_name>Romain Jouffroy</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>lactate</keyword>
  <keyword>prehospital</keyword>
  <keyword>prediction</keyword>
  <keyword>mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlactatemia</mesh_term>
  </condition_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/NCT03831685
org study id: LAPHSUS study
nct id: NCT03831685
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the pre-hospital setting, the severity assessment of septic shock is essential to decide
      the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a
      need for an additional element in order to enhance the severity assessment and to decide
      in-hospital admission in the intensive care unit (ICU) or in the emergency department (ED).
      Point of care medical device yielding blood lactate levels since the pre-hospital setting may
      give an easy and valuable element for the severity assessment and the decision-making.

      The aim of this study is to provide clinical evidence that the pre-hospital blood lactate
      level predicts the 30-day mortality of patients with septic shock.
This trial is a prospective, observational, non-randomized controlled study. A total of 1000
      patients requiring mobile intensive care unit intervention for a septic shock in the
      pre-hospital setting will be included. Pre-hospital blood lactate levels will not be taken
      into account to decide patients treatments and/or ED or ICU admission. In the pre-hospital
      setting, each patient will benefit from 2 measurements of blood lactate level: initial
      measurement at the first contact, and final measurement at the hospital admission with a
      specific point of care medical device.
observational model: Cohort
time perspective: Prospective
measure: Mortality after inclusion
time frame: 30 days
description: mortality rate
measure: Intensive Care Unit length of stay
time frame: 90 days
description: Duration of ICU length of stay
measure: Hospital length of stay
time frame: 90 days
description: Duration of Hospital length of stay
measure: Mechanical ventilatory support
time frame: 30 days
description: Duration of mechanical ventilation
measure: Hemodynamic support
time frame: 30 days
description: Duration of catecholamines' infusion
measure: Duration of hemodiaflitration
time frame: 30 days
description: Duration of extra renal support
intervention type: Other
intervention name: Blood sample
description: Patients meeting the inclusion criteria and none of the non-inclusion criteria will benefit from 2 venous blood samples in order to precise the initial blood lactate level, e.g. at the first medical contact, and the final blood lactate level, e.g. at the hospital admission.
Venous blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Romain Jouffroy, MD
role: Principal Investigator
affiliation: APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit
last name: Romain Jouffroy, MD
phone: +33144495989
email: romain.jouffroy@gmail.com
last name: Benoit Vivien, MD, PhD
phone: +3314492424
email: benoit.vivien@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
citation: Marecaux G, Pinsky MR, Dupont E, Kahn RJ, Vincent JL. Blood lactate levels are better prognostic indicators than TNF and IL-6 levels in patients with septic shock. Intensive Care Med. 1996 May;22(5):404-8. doi: 10.1007/BF01712155.
PMID: 8796390
citation: Bakker J, Coffernils M, Leon M, Gris P, Vincent JL. Blood lactate levels are superior to oxygen-derived variables in predicting outcome in human septic shock. Chest. 1991 Apr;99(4):956-62. doi: 10.1378/chest.99.4.956.
PMID: 2009802
citation: Cicarelli DD, Vieira JE, Bensenor FE. [Lactate as a predictor of mortality and multiple organ failure in patients with the systemic inflammatory response syndrome.]. Rev Bras Anestesiol. 2007 Dec;57(6):630-8. doi: 10.1590/s0034-70942007000600005. Portuguese.
PMID: 19462139
citation: Gaieski DF, Goyal M. Serum lactate as a predictor of mortality in emergency department patients with infection: does the lactate level tell the whole story? Ann Emerg Med. 2005 Dec;46(6):561-2; author reply 562. doi: 10.1016/j.annemergmed.2005.07.021. No abstract available.
PMID: 16308078
citation: Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.
PMID: 19325467
citation: Shapiro NI, Howell MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, Weiss JW. Serum lactate as a predictor of mortality in emergency department patients with infection. Ann Emerg Med. 2005 May;45(5):524-8. doi: 10.1016/j.annemergmed.2004.12.006.
PMID: 15855951
citation: Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, Parrillo JE, Dellinger RP, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009 Jul;32(1):35-9. doi: 10.1097/shk.0b013e3181971d47.
PMID: 19533847
responsible party type: Principal Investigator
investigator affiliation: Hôpital Necker-Enfants Malades
investigator full name: Romain Jouffroy
investigator title: PI
mesh term: Hyperlactatemia
sharing ipd: Undecided