<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/NCT03754257</url>
  </required_header>
  <id_info>
    <org_study_id>HSL 2018-26</org_study_id>
    <nct_id>NCT03754257</nct_id>
  </id_info>
  <brief_title>Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With Sepsis</brief_title>
  <official_title>Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With Sepsis and Septic Shock - Randomized, Controlled and Double-blind Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sirio-Libanes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Sirio-Libanes</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>
      Background: Electrical stimulation has been used in critical patients as an adjunct strategy&#xD;
      of early rehabilitation. In septic or septic shock patients there are reports of only two&#xD;
      studies in the literature, with conflicting results.&#xD;
&#xD;
      Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass&#xD;
      loss in patients admitted to the ICU with sepsis or septic shock.&#xD;
&#xD;
      Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients&#xD;
      with a diagnosis of sepsis or septic shock (including patients with sepsis due to the new&#xD;
      coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They&#xD;
      will be evaluated in relation to muscle mass, peripheral muscle strength and functional&#xD;
      status. They will also be submitted to the collection of inflammatory, metabolic, damage and&#xD;
      muscular trophism markers.&#xD;
&#xD;
      Expected results: Electrical stimulation is expected to be able to prevent loss of muscle&#xD;
      mass in patients admitted to the ICU with sepsis or septic shock. In addition, it is expected&#xD;
      to be able to preserve strength in this population without increasing the pro-inflammatory or&#xD;
      metabolic response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a&#xD;
      diagnosis of sepsis or septic shock (including patients with sepsis due to the new&#xD;
      coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They&#xD;
      will be evaluated in relation to muscle mass, peripheral muscle strength and functional&#xD;
      status. They will also be submitted to the collection of inflammatory, metabolic, damage and&#xD;
      muscular trophism markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2023</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle mass</measure>
    <time_frame>8 days</time_frame>
    <description>Cross-sectional area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle mass</measure>
    <time_frame>8 days</time_frame>
    <description>Thickness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peripheral muscle strength</measure>
    <time_frame>8 days</time_frame>
    <description>Medical Research Council Scale will be used to measure the peripheral muscle strength. The patient's effort is graded on a scale of 0-5:&#xD;
Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.&#xD;
Grade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side.&#xD;
Grade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.&#xD;
Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.&#xD;
Grade 0: No movement is observed. The total score ranges from 0 (complete tetraparesis) to 60 points (normal muscle strength).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory</measure>
    <time_frame>8 days</time_frame>
    <description>IL-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory</measure>
    <time_frame>8 days</time_frame>
    <description>IL-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional status</measure>
    <time_frame>8 days</time_frame>
    <description>Functional status will be assessed using the Surgical Intensive Care Unit Optimal Mobilization Score. This score classifies mobility from 0 to 4:&#xD;
The SOMS &quot;0 - No mobility&quot; indicates that no mobilization should be considered due to the patients' clinical status.&#xD;
SOMS &quot;1 - Passive mobilization&quot; indicates that passive mobilization can be carried out in bed.&#xD;
SOMS &quot;2 - Sitting&quot; demonstrates that the patient is already able to sit on the bed or in a chair.&#xD;
SOMS &quot;3 - Standing&quot;, indicates that the patient can perform orthostatism, with or without assistance.&#xD;
The highest level of SOMS &quot;4 - Ambulation&quot;, shows that the patient is capable of ambulation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Experimental Electrical Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Electrical Stimulation for 40 minutos + conventional physiotherapy, during seven days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Electrical Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Electrical Stimulation for 40 minutes + conventional physiotherapy, during seven days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Experimental Electrical Stimulation</intervention_name>
    <description>Experimental Electrical Stimulation (100Hz) during 40 minutes</description>
    <arm_group_label>Experimental Electrical Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Electrical Stimulation</intervention_name>
    <description>Sham Electrical Stimulation (5Hz) during 40 minutes</description>
    <arm_group_label>Sham Electrical Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Physiotherapy</intervention_name>
    <description>Active and passive exercises, and walking.</description>
    <arm_group_label>Experimental Electrical Stimulation</arm_group_label>
    <arm_group_label>Sham Electrical Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients admitted to the ICU with a diagnosis of sepsis or septic shock,&#xD;
&#xD;
          -  aged ≥ 18 years,&#xD;
&#xD;
          -  body mass index (BMI) ≤ 35 kg / m2,&#xD;
&#xD;
          -  without diabetic polyneuropathy,&#xD;
&#xD;
          -  without cardiac pacemaker,&#xD;
&#xD;
          -  without diagnosis of neuromuscular diseases,&#xD;
&#xD;
          -  absence of skin lesions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart attack,&#xD;
&#xD;
          -  death.&#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>Wellington Yamaguti, PHD</last_name>
    <phone>1133940200</phone>
    <phone_ext>4395</phone_ext>
    <email>wellington.psyamaguti@hsl.org.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Samantha Grams, MSC</last_name>
    <phone>1133940200</phone>
    <phone_ext>4395</phone_ext>
    <email>samantha.tgrams@hsl.org.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Sírio-Libanês</name>
      <address>
        <city>São Paulo</city>
        <zip>01308050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wellington P Yamaguti, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Samantha T Grams, Msc</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Sirio-Libanes</investigator_affiliation>
    <investigator_full_name>Wellington Yamaguti</investigator_full_name>
    <investigator_title>Wellington Pereira dos Santos Yamaguti</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>septic shock</keyword>
  <keyword>electrical stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <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/NCT03754257
org study id: HSL 2018-26
nct id: NCT03754257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Electrical stimulation has been used in critical patients as an adjunct strategy
      of early rehabilitation. In septic or septic shock patients there are reports of only two
      studies in the literature, with conflicting results.

      Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass
      loss in patients admitted to the ICU with sepsis or septic shock.

      Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients
      with a diagnosis of sepsis or septic shock (including patients with sepsis due to the new
      coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They
      will be evaluated in relation to muscle mass, peripheral muscle strength and functional
      status. They will also be submitted to the collection of inflammatory, metabolic, damage and
      muscular trophism markers.

      Expected results: Electrical stimulation is expected to be able to prevent loss of muscle
      mass in patients admitted to the ICU with sepsis or septic shock. In addition, it is expected
      to be able to preserve strength in this population without increasing the pro-inflammatory or
      metabolic response.
This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a
      diagnosis of sepsis or septic shock (including patients with sepsis due to the new
      coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They
      will be evaluated in relation to muscle mass, peripheral muscle strength and functional
      status. They will also be submitted to the collection of inflammatory, metabolic, damage and
      muscular trophism markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Muscle mass
time frame: 8 days
description: Cross-sectional area
measure: Muscle mass
time frame: 8 days
description: Thickness
measure: Peripheral muscle strength
time frame: 8 days
description: Medical Research Council Scale will be used to measure the peripheral muscle strength. The patient's effort is graded on a scale of 0-5:
Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.
Grade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side.
Grade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.
Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.
Grade 0: No movement is observed. The total score ranges from 0 (complete tetraparesis) to 60 points (normal muscle strength).
measure: Inflammatory
time frame: 8 days
description: IL-6
measure: Inflammatory
time frame: 8 days
description: IL-10
measure: Functional status
time frame: 8 days
description: Functional status will be assessed using the Surgical Intensive Care Unit Optimal Mobilization Score. This score classifies mobility from 0 to 4:
The SOMS "0 - No mobility" indicates that no mobilization should be considered due to the patients' clinical status.
SOMS "1 - Passive mobilization" indicates that passive mobilization can be carried out in bed.
SOMS "2 - Sitting" demonstrates that the patient is already able to sit on the bed or in a chair.
SOMS "3 - Standing", indicates that the patient can perform orthostatism, with or without assistance.
The highest level of SOMS "4 - Ambulation", shows that the patient is capable of ambulation.
arm group label: Experimental Electrical Stimulation
arm group type: Experimental
description: Experimental Electrical Stimulation for 40 minutos + conventional physiotherapy, during seven days.
arm group label: Sham Electrical Stimulation
arm group type: Sham Comparator
description: Sham Electrical Stimulation for 40 minutes + conventional physiotherapy, during seven days.
intervention type: Procedure
intervention name: Experimental Electrical Stimulation
description: Experimental Electrical Stimulation (100Hz) during 40 minutes
arm group label: Experimental Electrical Stimulation
intervention type: Procedure
intervention name: Sham Electrical Stimulation
description: Sham Electrical Stimulation (5Hz) during 40 minutes
arm group label: Sham Electrical Stimulation
intervention type: Other
intervention name: Conventional Physiotherapy
description: Active and passive exercises, and walking.
arm group label: Experimental Electrical Stimulation
arm group label: Sham Electrical Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wellington Yamaguti, PHD
phone: 1133940200
phone ext: 4395
email: wellington.psyamaguti@hsl.org.br
last name: Samantha Grams, MSC
phone: 1133940200
phone ext: 4395
email: samantha.tgrams@hsl.org.br
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Sirio-Libanes
investigator full name: Wellington Yamaguti
investigator title: Wellington Pereira dos Santos Yamaguti
mesh term: Sepsis
mesh term: Toxemia
mesh term: Shock, Septic
mesh term: Shock
sharing ipd: No