<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/NCT03768700</url>
  </required_header>
  <id_info>
    <org_study_id>NI17008J</org_study_id>
    <secondary_id>2018-A00743-52</secondary_id>
    <nct_id>NCT03768700</nct_id>
  </id_info>
  <brief_title>Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR)</brief_title>
  <acronym>Cohorte-SRPR</acronym>
  <official_title>Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR)</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>
      Non-interventional cohort study (on data), prospective national multicenter. Inclusion of&#xD;
      patients as they enter in a post-intensive care rehabilitation unit (SRPR) .&#xD;
&#xD;
      Collection of data after inclusion, from patients' records during their stay (weekly&#xD;
      follow-up) to the SRPR and at their discharge, to D28, D90 and at 1 year after their&#xD;
      hospitalization from hospital reports or call of the attending physician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For one year, all patients, adults and children hospitalized in a post-intensive care&#xD;
      rehabilitation unit (SRPR) of Ile de France and Rouen will be offered to participate in the&#xD;
      SRPR Cohort in order to have a completeness of data on a new practice.&#xD;
&#xD;
      The study of these data will make it possible to know the future of the patients and to&#xD;
      establish criteria prior to the admission in the SRPR which could make it possible to predict&#xD;
      this future and to select the patients as well as possible. It will also make it possible to&#xD;
      know the impact of care on the outcome of patients at discharge, at 28 days, 90 days and 1&#xD;
      year of their admission to SRPR to improve practices.&#xD;
&#xD;
      This research will focus on the collection of data from patients' medical records. General&#xD;
      information about their stay in the intensive care unit - including the patient's ventilatory&#xD;
      status - will be collected upon arrival at the SRPR units, during their stay (weekly&#xD;
      follow-up), at the exit of the SRPR, at D28, and in the longer term. (J90 and J365 of the&#xD;
      entry into the SRPR unit) where will be listed more comprehensive data with, in addition to&#xD;
      general information, data on nutritional, neurological, neuromuscular, respiratory and&#xD;
      biological hemodynamic assessments will be collected.&#xD;
&#xD;
      In addition to the common data base, each type of SRPR (respiratory and pediatric neurology)&#xD;
      will collect data that is specific to its specialty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Anticipated">August 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2025</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Ventilation status of patients discharged from SRPR</measure>
    <time_frame>28 days</time_frame>
    <description>Describe the ventilatory status of patients hospitalized in SRPR at the SRPR exit: during the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional status assessed by the functional independence measurement scale (MIF) at entry to the SRPR and weekly follow-up during the stay and discharge of the SRPR, at discharge from the hospital, at Day 28, Day 90 and at 1 year.</measure>
    <time_frame>one year</time_frame>
    <description>Describe the clinico-biological characteristics of patients prior to admission to SRPRs and their future in order to better select them.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital status at the exit of the SRPR at Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.</measure>
    <time_frame>Between the exit of the SRPR and up to one year after entry into the SRPR unit</time_frame>
    <description>The only one parameters that we will measure will be vital status: alive or not?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory status at discharge from the hospital, Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.</measure>
    <time_frame>Between the exit of the SRPR and up to one year after entry into the SRPR unit</time_frame>
    <description>During the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in intensive care unit, SRPR and hospital</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of swallowing of patients</measure>
    <time_frame>one day</time_frame>
    <description>Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of nutrition of patients</measure>
    <time_frame>one day</time_frame>
    <description>Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of nutritional status of patients</measure>
    <time_frame>one day</time_frame>
    <description>Evaluate by clinical data recorded in the medical file: weight in kilograms, height in meters and a combined BMI= weight/height in kg/m^2) and measurement of albumin (g/l) and measurement of prealbuminemia (g/l) at upon entry into SRPR service.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Hospitalization in a Post-Resuscitation Rehabilitation Care Units</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data gathering</intervention_name>
    <description>Questionnaires and collection of medical data on patients during hospitalization, at D28, at 90 and at 1 year</description>
    <arm_group_label>Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France&#xD;
        and Rouen&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de&#xD;
             France and Rouen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of access to the data by the patient or the designated trusted person or the&#xD;
             holder (s) of parental authority (pediatric population)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre DEMOULE, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Pitié-Salpêtrière - AP-HP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexandre DEMOULE, Pr</last_name>
    <phone>0142167727</phone>
    <email>alexandre.demoule@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julie DELEMAZURE, Dr</last_name>
    <phone>0184827572</phone>
    <email>julie.delemazure@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Groupe hospitalier des portes de l'Oise</name>
      <address>
        <city>Beaumont-sur-Oise</city>
        <zip>95260</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Eric BOUDET, Dr</last_name>
      <email>eric.boulet@ch-pontoise.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Bligny</name>
      <address>
        <city>Briis-sous-Forges</city>
        <zip>91640</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Henry MAAS, Dr</last_name>
      <email>h.maas@chbligny.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital d'instruction des armées - Percy</name>
      <address>
        <city>Clamart</city>
        <zip>92190</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>David ROGEZ, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital de Forcilles</name>
      <address>
        <city>Férolles-Attilly</city>
        <zip>77150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Laurence DONETTI, Dr</last_name>
      <email>ldonetti@cognac-jay.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Raymond Poincaré - SRPR pédiatrique</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Blaise MBIELEU, Dr</last_name>
      <email>blaise.mbieleu@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Raymond Poincaré de Garches - SRPR neurologique</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Julie PAQUEREAU, Dr</last_name>
      <email>julie.paquereau@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bernard VIGUE, Dr</last_name>
      <email>bernard.vigue@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandre DEMOULE, Pr</last_name>
      <phone>0142167727</phone>
      <email>alexandre.demoule@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Julie DELEMAZURE, Dr</last_name>
      <phone>0184827572</phone>
      <email>julie.delemazure@aphp.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hôpital Sainte-Anne</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Florence COLLE, Dr</last_name>
      <email>f.colle@ch-sainte-anne.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles-Nicolle - CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gaëtan BEDUNEAU, Dr</last_name>
      <email>Gaetan.beduneau@chu-rouen.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03768700
org study id: NI17008J
secondary id: 2018-A00743-52
nct id: NCT03768700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-interventional cohort study (on data), prospective national multicenter. Inclusion of
      patients as they enter in a post-intensive care rehabilitation unit (SRPR) .

      Collection of data after inclusion, from patients' records during their stay (weekly
      follow-up) to the SRPR and at their discharge, to D28, D90 and at 1 year after their
      hospitalization from hospital reports or call of the attending physician.
For one year, all patients, adults and children hospitalized in a post-intensive care
      rehabilitation unit (SRPR) of Ile de France and Rouen will be offered to participate in the
      SRPR Cohort in order to have a completeness of data on a new practice.

      The study of these data will make it possible to know the future of the patients and to
      establish criteria prior to the admission in the SRPR which could make it possible to predict
      this future and to select the patients as well as possible. It will also make it possible to
      know the impact of care on the outcome of patients at discharge, at 28 days, 90 days and 1
      year of their admission to SRPR to improve practices.

      This research will focus on the collection of data from patients' medical records. General
      information about their stay in the intensive care unit - including the patient's ventilatory
      status - will be collected upon arrival at the SRPR units, during their stay (weekly
      follow-up), at the exit of the SRPR, at D28, and in the longer term. (J90 and J365 of the
      entry into the SRPR unit) where will be listed more comprehensive data with, in addition to
      general information, data on nutritional, neurological, neuromuscular, respiratory and
      biological hemodynamic assessments will be collected.

      In addition to the common data base, each type of SRPR (respiratory and pediatric neurology)
      will collect data that is specific to its specialty.
observational model: Cohort
time perspective: Prospective
measure: Ventilation status of patients discharged from SRPR
time frame: 28 days
description: Describe the ventilatory status of patients hospitalized in SRPR at the SRPR exit: during the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?
measure: Functional status assessed by the functional independence measurement scale (MIF) at entry to the SRPR and weekly follow-up during the stay and discharge of the SRPR, at discharge from the hospital, at Day 28, Day 90 and at 1 year.
time frame: one year
description: Describe the clinico-biological characteristics of patients prior to admission to SRPRs and their future in order to better select them.
measure: Vital status at the exit of the SRPR at Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.
time frame: Between the exit of the SRPR and up to one year after entry into the SRPR unit
description: The only one parameters that we will measure will be vital status: alive or not?
measure: Ventilatory status at discharge from the hospital, Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.
time frame: Between the exit of the SRPR and up to one year after entry into the SRPR unit
description: During the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?
measure: Length of stay in intensive care unit, SRPR and hospital
time frame: one year
measure: Evaluation of swallowing of patients
time frame: one day
description: Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
measure: Evaluation of nutrition of patients
time frame: one day
description: Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
measure: Evaluation of nutritional status of patients
time frame: one day
description: Evaluate by clinical data recorded in the medical file: weight in kilograms, height in meters and a combined BMI= weight/height in kg/m^2) and measurement of albumin (g/l) and measurement of prealbuminemia (g/l) at upon entry into SRPR service.
arm group label: Cohort
description: Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR)
intervention type: Other
intervention name: Data gathering
description: Questionnaires and collection of medical data on patients during hospitalization, at D28, at 90 and at 1 year
arm group label: Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alexandre DEMOULE, Pr
role: Principal Investigator
affiliation: Hôpital Pitié-Salpêtrière - AP-HP
last name: Alexandre DEMOULE, Pr
phone: 0142167727
email: alexandre.demoule@aphp.fr
last name: Julie DELEMAZURE, Dr
phone: 0184827572
email: julie.delemazure@aphp.fr
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No