<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/NCT03802500</url>
  </required_header>
  <id_info>
    <org_study_id>NRA-01</org_study_id>
    <nct_id>NCT03802500</nct_id>
  </id_info>
  <brief_title>Neurophysiological Diagnosis for ICU Septic Shock Patients</brief_title>
  <acronym>EDX</acronym>
  <official_title>Early Electromyographic Evaluation of the ICU-acquired Weakness in Septic Shock Patients Ventilated Longer Than 72 Hours: Neurophysiological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe&#xD;
      disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The&#xD;
      causes of this weakness are multiple and the physiopathology is still not fully understood.&#xD;
      Immobilization in bed and sepsis are known risk factors.&#xD;
&#xD;
      ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and&#xD;
      increased in ICU and hospital length of stay. It has also been associated with significant&#xD;
      decrease in functional capacity and with higher mortality. An early screening using a&#xD;
      specific diagnostic protocol could help improving the management of patients suffering from&#xD;
      ICU acquired weakness.&#xD;
&#xD;
      The aim of this study is to early detect ICU acquired weakness in patients suffering from&#xD;
      septic shock and ventilated for more than 72 hours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.</measure>
    <time_frame>72 hours</time_frame>
    <description>Medical Research Council strength scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge destination</measure>
    <time_frame>At discharge from hospital, up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ventilatory support</measure>
    <time_frame>At extubation, up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation failure rate</measure>
    <time_frame>up to 72 hours, after first extubation</time_frame>
    <description>Patients requiring reintubation 72 hours after failed first extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time elapsed between endotracheal intubation and first out-of-bed mobilization</measure>
    <time_frame>up to 6 months, at first out-of-bed mobilization</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>ICU Acquired Weakness</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Nerve conduction study</intervention_name>
    <description>Physical examination of muscle strength is conducted using the Medical Research Council (MRC) scale in 6 muscles bilaterally.&#xD;
Patients with an MRC score of less than 48 of 60 are diagnosed with critical illness polyneuromyopathy (CIPNM).&#xD;
The evaluation is completed by a routine neurological examination. In patients meeting the inclusion criteria, the screening Peroneal nerve test (PENT test) is performed on the day of study enrollment and subsequently in 1 week intervals until pathologic findings are detected or patient is discharged from the ICU.&#xD;
PENT measures the peroneal nerve Compound muscle action potential (CMAP) amplitude in one leg. If the PENT is normal, the contra-lateral peroneal nerve is measured. An abnormal condition is identified if the peroneal nerve CMAP amplitude is reduced below the normal limits of the participating centre in at least one leg. In Lausanne, the abnormal response is &lt; 2,5 mV.</description>
    <other_name>Peroneal nerve test (PENT test)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospitalization for more than 7 days before intubation.&#xD;
&#xD;
          -  Functional disability at admission of ≥4 (Requires constant nursing care and&#xD;
             attention, bedridden, incontinent) in the Modified Rankin Scale.&#xD;
&#xD;
          -  Lower limb disorders precluding nerve conduction studies (NCV) and electromyography&#xD;
             (EMG), such as clinical edema of the lower limbs, or fractures, amputation, and&#xD;
             plaster casts of the lower limbs.&#xD;
&#xD;
          -  Evidence of altered neuromuscular transmission at repetitive stimulation test either&#xD;
             caused by neuromuscular blocking agents or disease.&#xD;
&#xD;
          -  Burn patients admitted to ICU.&#xD;
&#xD;
          -  Patient requesting withdrawal of therapies.&#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_official>
    <last_name>Karin Diserens, PD-MER</last_name>
    <role>Study Director</role>
    <affiliation>NRA Unit. CHUV.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>CAROLINE ATTWELL</last_name>
    <phone>0789242320</phone>
    <email>caroline.attwell@chuv.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHUV</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CAROLINE ATTWELL</last_name>
      <phone>0795567994</phone>
      <email>caroline.attwell@chuv.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>October 3, 2019</last_update_submitted>
  <last_update_submitted_qc>October 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>CAROLINE ATTWELL</investigator_full_name>
    <investigator_title>Mrs</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthenia</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/NCT03802500
org study id: NRA-01
nct id: NCT03802500
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe
      disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The
      causes of this weakness are multiple and the physiopathology is still not fully understood.
      Immobilization in bed and sepsis are known risk factors.

      ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and
      increased in ICU and hospital length of stay. It has also been associated with significant
      decrease in functional capacity and with higher mortality. An early screening using a
      specific diagnostic protocol could help improving the management of patients suffering from
      ICU acquired weakness.

      The aim of this study is to early detect ICU acquired weakness in patients suffering from
      septic shock and ventilated for more than 72 hours.
observational model: Case-Only
time perspective: Prospective
measure: Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.
time frame: 72 hours
description: Medical Research Council strength scale
measure: ICU length of stay
time frame: Up to 6 months
measure: Hospital length of stay
time frame: Up to 6 months
measure: Discharge destination
time frame: At discharge from hospital, up to 6 months
measure: Length of ventilatory support
time frame: At extubation, up to 6 months
measure: Extubation failure rate
time frame: up to 72 hours, after first extubation
description: Patients requiring reintubation 72 hours after failed first extubation
measure: Time elapsed between endotracheal intubation and first out-of-bed mobilization
time frame: up to 6 months, at first out-of-bed mobilization
intervention type: Diagnostic Test
intervention name: Nerve conduction study
description: Physical examination of muscle strength is conducted using the Medical Research Council (MRC) scale in 6 muscles bilaterally.
Patients with an MRC score of less than 48 of 60 are diagnosed with critical illness polyneuromyopathy (CIPNM).
The evaluation is completed by a routine neurological examination. In patients meeting the inclusion criteria, the screening Peroneal nerve test (PENT test) is performed on the day of study enrollment and subsequently in 1 week intervals until pathologic findings are detected or patient is discharged from the ICU.
PENT measures the peroneal nerve Compound muscle action potential (CMAP) amplitude in one leg. If the PENT is normal, the contra-lateral peroneal nerve is measured. An abnormal condition is identified if the peroneal nerve CMAP amplitude is reduced below the normal limits of the participating centre in at least one leg. In Lausanne, the abnormal response is < 2,5 mV.
other name: Peroneal nerve test (PENT test)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karin Diserens, PD-MER
role: Study Director
affiliation: NRA Unit. CHUV.
last name: CAROLINE ATTWELL
phone: 0789242320
email: caroline.attwell@chuv.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: CAROLINE ATTWELL
investigator title: Mrs
mesh term: Asthenia
sharing ipd: No