<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/NCT03831022</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02588-47</org_study_id>
    <nct_id>NCT03831022</nct_id>
  </id_info>
  <brief_title>Usefulness of Capillary Refill Time and Skin Mottling Score to Predict Intensive Care Unit Admission</brief_title>
  <acronym>TRCMARBSAU</acronym>
  <official_title>Contribution of Capillary Refilling Time and Skin Mottling Score to Predict Intensive Care Unit Admission of Patients With Septic or Haemorrhagic Shock Admitted to the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Necker-Enfants Malades</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hôpital Cochin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Grenoble Alps</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Begin Military Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Argenteuil Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Marseille</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 emergency department (ED), the severity assessment of shock is a fundamental step&#xD;
      prior to the admission in intensive care unit (ICU). As biomarkers are time consuming to&#xD;
      evaluate severity of the micro and macro-circulation alteration, capillary refill time and&#xD;
      skin mottling score are 2 simples, available clinical criteria validated to predict mortality&#xD;
      in the ICU.&#xD;
&#xD;
      The aim of this study is to provide clinical evidence that capillary refill time and skin&#xD;
      mottling score assessed in the ED also predict ICU admission of patients with septic or&#xD;
      haemorrhagic shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is an observational, non-randomized controlled study. A total of 1500 patients&#xD;
      admitted to the ED for a septic or hemorrhagic shock will be followed.&#xD;
&#xD;
      The primary outcome is the admission to the ICU.&#xD;
&#xD;
      The study will not impact the treatments provided to each patient. Capillary refill time and&#xD;
      skin mottling score will not be taken into account to decide patient's treatments and/or ICU&#xD;
      admission. Patients will be followed during their hospital stay in order to precise their&#xD;
      destination after ED (home, ICU, ward) and 28- and 90-days mortality after hospital&#xD;
      admission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">December 17, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 17, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>90 Days</target_duration>
  <primary_outcome>
    <measure>Rate of ICU admission after ED.</measure>
    <time_frame>2 days</time_frame>
    <description>The rate of ICU admission after ED will be monitored for each patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality on day 30 after hospital admission</measure>
    <time_frame>30 days</time_frame>
    <description>The vital status (alive or deceased) will be recorded on day 30 after hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality on day 90 after hospital admission</measure>
    <time_frame>90 days</time_frame>
    <description>The vital status (alive or deceased) will be recorded on day 90 after hospital admission</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Shock, Septic</condition>
  <condition>Shock, Hemorrhagic</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Capillary refill time and skin mottling score measurement at the admission to the emergency department</intervention_name>
    <description>Patients who meet the inclusion criteria and none of the non-inclusion criteria will benefit from capillary refill time and skin mottling score measurement at the admission to the emergency department (ED) and followed during their hospital stay to precise the destination after ED (home, ICU, ward) and 30- and 90-days mortality after hospital admission.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the ED for septic or haemorrhagic shock&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years&#xD;
&#xD;
          2. Skin mottling score&gt; 2 and/or capillary refill time &gt; 3secondes associated with at&#xD;
             least one of the followings measured at the ED admission by the nurse in charge of the&#xD;
             patient:&#xD;
&#xD;
               1. Systolic blood pressure &lt; 90mmHg or blood pressure decrease of 30% at least for&#xD;
                  patients with high blood pressure history&#xD;
&#xD;
               2. Heart rate &gt; 120 beats per minute&#xD;
&#xD;
               3. Respiratory rate &gt; 22 movements per minute&#xD;
&#xD;
               4. Glasgow coma scale &lt; 13.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 18 years&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. Serious co morbid conditions with a not to be reanimated status known at the ED&#xD;
             admission&#xD;
&#xD;
          4. 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>No</healthy_volunteers>
  </eligibility>
  <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>+33144492424</phone>
    <email>benoit.vivien@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Necker enfants malades Hospital</name>
      <address>
        <city>Paris</city>
        <state>Ile De France</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain Jouffroy, MD</last_name>
      <phone>+33144495989</phone>
      <email>romain.jouffroy@gmail.com</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>Emmanuel Bloch-Laine, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierrick Le Borgne, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maxime Maignan, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas Marjanovic, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Lafon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Léa Thomas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scarlett Dehdar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre Michelet, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Pottecher T, Calvat S, Dupont H, Durand-Gasselin J, Gerbeaux P; SFAR/SRLF workgroup. Haemodynamic management of severe sepsis: recommendations of the French Intensive Care Societies (SFAR/SRLF) Consensus Conference, 13 October 2005, Paris, France. Crit Care. 2006;10(4):311. doi: 10.1186/cc4965.</citation>
    <PMID>16941754</PMID>
  </reference>
  <reference>
    <citation>Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.</citation>
    <PMID>8844239</PMID>
  </reference>
  <reference>
    <citation>Pickard A, Karlen W, Ansermino JM. Capillary refill time: is it still a useful clinical sign? Anesth Analg. 2011 Jul;113(1):120-3. doi: 10.1213/ANE.0b013e31821569f9. Epub 2011 Apr 25.</citation>
    <PMID>21519051</PMID>
  </reference>
  <reference>
    <citation>Ait-Oufella H, Bige N, Boelle PY, Pichereau C, Alves M, Bertinchamp R, Baudel JL, Galbois A, Maury E, Guidet B. Capillary refill time exploration during septic shock. Intensive Care Med. 2014 Jul;40(7):958-64. doi: 10.1007/s00134-014-3326-4. Epub 2014 May 9.</citation>
    <PMID>24811942</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>Lima A, Jansen TC, van Bommel J, Ince C, Bakker J. The prognostic value of the subjective assessment of peripheral perfusion in critically ill patients. Crit Care Med. 2009 Mar;37(3):934-8. doi: 10.1097/CCM.0b013e31819869db.</citation>
    <PMID>19237899</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>Mrgan M, Rytter D, Brabrand M. Capillary refill time is a predictor of short-term mortality for adult patients admitted to a medical department: an observational cohort study. Emerg Med J. 2014 Dec;31(12):954-8. doi: 10.1136/emermed-2013-202925. Epub 2013 Sep 17.</citation>
    <PMID>24045049</PMID>
  </reference>
  <reference>
    <citation>Jouffroy R, Saade A, Tourtier JP, Gueye P, Bloch-Laine E, Ecollan P, Carli P, Vivien B. Skin mottling score and capillary refill time to assess mortality of septic shock since pre-hospital setting. Am J Emerg Med. 2019 Apr;37(4):664-671. doi: 10.1016/j.ajem.2018.07.010. Epub 2018 Jul 6.</citation>
    <PMID>30001815</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 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>MD</investigator_title>
  </responsible_party>
  <keyword>shock</keyword>
  <keyword>sepsis</keyword>
  <keyword>haemoragy</keyword>
  <keyword>intensive care unit</keyword>
  <keyword>prediction</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>
    <mesh_term>Shock, Hemorrhagic</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/NCT03831022
org study id: 2018-A02588-47
nct id: NCT03831022
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the emergency department (ED), the severity assessment of shock is a fundamental step
      prior to the admission in intensive care unit (ICU). As biomarkers are time consuming to
      evaluate severity of the micro and macro-circulation alteration, capillary refill time and
      skin mottling score are 2 simples, available clinical criteria validated to predict mortality
      in the ICU.

      The aim of this study is to provide clinical evidence that capillary refill time and skin
      mottling score assessed in the ED also predict ICU admission of patients with septic or
      haemorrhagic shock.
This trial is an observational, non-randomized controlled study. A total of 1500 patients
      admitted to the ED for a septic or hemorrhagic shock will be followed.

      The primary outcome is the admission to the ICU.

      The study will not impact the treatments provided to each patient. Capillary refill time and
      skin mottling score will not be taken into account to decide patient's treatments and/or ICU
      admission. Patients will be followed during their hospital stay in order to precise their
      destination after ED (home, ICU, ward) and 28- and 90-days mortality after hospital
      admission.
observational model: Cohort
time perspective: Prospective
measure: Rate of ICU admission after ED.
time frame: 2 days
description: The rate of ICU admission after ED will be monitored for each patient
measure: Mortality on day 30 after hospital admission
time frame: 30 days
description: The vital status (alive or deceased) will be recorded on day 30 after hospital admission
measure: Mortality on day 90 after hospital admission
time frame: 90 days
description: The vital status (alive or deceased) will be recorded on day 90 after hospital admission
intervention type: Other
intervention name: Capillary refill time and skin mottling score measurement at the admission to the emergency department
description: Patients who meet the inclusion criteria and none of the non-inclusion criteria will benefit from capillary refill time and skin mottling score measurement at the admission to the emergency department (ED) and followed during their hospital stay to precise the destination after ED (home, ICU, ward) and 30- and 90-days mortality after hospital admission.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Romain Jouffroy, MD
phone: +33144495989
email: romain.jouffroy@gmail.com
last name: Benoit Vivien, MD, PhD
phone: +33144492424
email: benoit.vivien@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
citation: Pottecher T, Calvat S, Dupont H, Durand-Gasselin J, Gerbeaux P; SFAR/SRLF workgroup. Haemodynamic management of severe sepsis: recommendations of the French Intensive Care Societies (SFAR/SRLF) Consensus Conference, 13 October 2005, Paris, France. Crit Care. 2006;10(4):311. doi: 10.1186/cc4965.
PMID: 16941754
citation: Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
PMID: 8844239
citation: Pickard A, Karlen W, Ansermino JM. Capillary refill time: is it still a useful clinical sign? Anesth Analg. 2011 Jul;113(1):120-3. doi: 10.1213/ANE.0b013e31821569f9. Epub 2011 Apr 25.
PMID: 21519051
citation: Ait-Oufella H, Bige N, Boelle PY, Pichereau C, Alves M, Bertinchamp R, Baudel JL, Galbois A, Maury E, Guidet B. Capillary refill time exploration during septic shock. Intensive Care Med. 2014 Jul;40(7):958-64. doi: 10.1007/s00134-014-3326-4. Epub 2014 May 9.
PMID: 24811942
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: Lima A, Jansen TC, van Bommel J, Ince C, Bakker J. The prognostic value of the subjective assessment of peripheral perfusion in critically ill patients. Crit Care Med. 2009 Mar;37(3):934-8. doi: 10.1097/CCM.0b013e31819869db.
PMID: 19237899
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: Mrgan M, Rytter D, Brabrand M. Capillary refill time is a predictor of short-term mortality for adult patients admitted to a medical department: an observational cohort study. Emerg Med J. 2014 Dec;31(12):954-8. doi: 10.1136/emermed-2013-202925. Epub 2013 Sep 17.
PMID: 24045049
citation: Jouffroy R, Saade A, Tourtier JP, Gueye P, Bloch-Laine E, Ecollan P, Carli P, Vivien B. Skin mottling score and capillary refill time to assess mortality of septic shock since pre-hospital setting. Am J Emerg Med. 2019 Apr;37(4):664-671. doi: 10.1016/j.ajem.2018.07.010. Epub 2018 Jul 6.
PMID: 30001815
responsible party type: Principal Investigator
investigator affiliation: Hôpital Necker-Enfants Malades
investigator full name: Romain Jouffroy
investigator title: MD
mesh term: Shock, Septic
mesh term: Shock
mesh term: Shock, Hemorrhagic
sharing ipd: Undecided