<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/NCT01717651</url>
  </required_header>
  <id_info>
    <org_study_id>2011H0290</org_study_id>
    <nct_id>NCT01717651</nct_id>
  </id_info>
  <brief_title>Muscle Atrophy in Patients With Severe Sepsis</brief_title>
  <official_title>Muscle Atrophy in Patients With Severe Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to help determine whether patients with severe sepsis (overwhelming&#xD;
      inflammation in the body as a result of an infection) lose muscle and become weak more&#xD;
      rapidly than patients with other severe illnesses. Weakness and muscle loss that develops&#xD;
      after a severe illness is a serious problem. Patients who develop weakness and have a&#xD;
      decrease in muscle size often have to stay in the hospital longer and have a higher chance of&#xD;
      dying. At the current time, it is not clear whether certain severe illnesses are more likely&#xD;
      to cause weakness and muscle loss. This study will be done to measure the changes in muscle&#xD;
      size and strength as a result of each patient's illness&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An optional portion of the study is available to help determine if moving the leg repeatedly&#xD;
      with a mechanical device helps prevent muscle loss and weakness. In this optional portion of&#xD;
      the study, the subject would have a CPM (continuous passive motion) device attached to one of&#xD;
      the subject's legs intermittently over the next three days. Without any effort from the&#xD;
      subject , the machine would move the subjects leg back and forth (flexing at the hip and the&#xD;
      knee) repeatedly.&#xD;
&#xD;
      This machine is approved by the United States Food and Drug Administration (FDA) to treat&#xD;
      patients after they have knee replacement surgery to help preserve the range of motion of the&#xD;
      joint while minimizing risk of damage to the joint from more intensive exercise. The use of&#xD;
      the device for this study is investigational.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow accrual made study completion unfeasible&#xD;
  </why_stopped>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Quadriceps muscle cross sectional area change from day 0 to 7</measure>
    <time_frame>seven days</time_frame>
    <description>Serial measures of quadriceps muscle by non-invasive ultrasound on Day of enrollment and Day 7 after enrollment</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Severe Sepsis</condition>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>CPM device</arm_group_label>
    <description>a CPM (continuous passive motion) device attached to one of your legs intermittently over the next three days.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A) Inclusion Criteria&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Required mechanical ventilation for at least 24 hours&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        A) Inclusion Criteria&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Required mechanical ventilation for at least 24 hours&#xD;
&#xD;
        B) Exclusion Criteria&#xD;
&#xD;
          1. Ventilator liberation anticipated in the next 24 hours&#xD;
&#xD;
             a. Rationale: short duration of illness anticipated, preventing achievement of primary&#xD;
             endpoint&#xD;
&#xD;
          2. Known or suspected acute diagnosis of neuromuscular disease causing diffuse or lower&#xD;
             extremity weakness (e.g. CVA, spinal cord injury or lesion, Muscular dystrophy,&#xD;
             Myasthenia Gravis, GBS)&#xD;
&#xD;
             a. Rationale: chronic lower extremity weakness will impact anticipated physical&#xD;
             recovery and relevance of atrophy observations&#xD;
&#xD;
          3. Pre-existing lower extremity weakness caused by prior injury, neuromuscular or joint&#xD;
             disease&#xD;
&#xD;
             a. Rationale: Inability to participate in usual care therapy and CPM. Impacts&#xD;
             functional recovery&#xD;
&#xD;
          4. Wounds, dressings or injuries of the lower extremities or pelvis that prevent muscle&#xD;
             testing or CPM&#xD;
&#xD;
             a. Rationale: Inability to participate in US, exam or CPM&#xD;
&#xD;
          5. Patient's family, physician, or both not in favor of aggressive treatment of patient&#xD;
             that includes life-sustaining treatments or the presence of an advance directive&#xD;
             indicating the same a. Rationale: Unlikely to survive to seven day endpoint&#xD;
&#xD;
          6. More than seventy-two hours of continuous mechanical ventilation previously during&#xD;
             this hospitalization&#xD;
&#xD;
             a. Rationale: Atrophy mechanisms already active and may degrade ability to detect&#xD;
             early changes.&#xD;
&#xD;
          7. Non-English speaking subject or legally authorized representative&#xD;
&#xD;
             a. Rationale: This study does not have the funding necessary to translate consents and&#xD;
             inability to ensure cooperation with testing.&#xD;
&#xD;
          8. Subject and/or Legally authorized representative unavailable to provide informed&#xD;
             consent&#xD;
&#xD;
          9. Subject is a Prisoner&#xD;
&#xD;
         10. Pregnancy (excluded from CPM portion only) a. Rationale: Pregnant patients can develop&#xD;
             the supine hypotensive syndrome (where the uterus compromises venous return due to&#xD;
             compression of the IVC). This typically occurs only after 20 weeks gestation. To&#xD;
             assure safety, any patient who self identifies as pregnant or has a positive urine&#xD;
             pregnancy test on admission will not be offered CPM since it requires extended periods&#xD;
             in the supine position.&#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>Naeem A Ali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Medical Center - University Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>January 15, 2016</last_update_submitted>
  <last_update_submitted_qc>January 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Naeem Ali, MD</investigator_full_name>
    <investigator_title>Medical Director, Medical Intensive Care Unit (MICU);</investigator_title>
  </responsible_party>
  <keyword>Atrophy</keyword>
  <keyword>Muscle wasting</keyword>
  <keyword>Sepsis</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>Respiratory Insufficiency</mesh_term>
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <!-- 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/NCT01717651
org study id: 2011H0290
nct id: NCT01717651
lead sponsor: 
has dmc: No
This study is being done to help determine whether patients with severe sepsis (overwhelming
      inflammation in the body as a result of an infection) lose muscle and become weak more
      rapidly than patients with other severe illnesses. Weakness and muscle loss that develops
      after a severe illness is a serious problem. Patients who develop weakness and have a
      decrease in muscle size often have to stay in the hospital longer and have a higher chance of
      dying. At the current time, it is not clear whether certain severe illnesses are more likely
      to cause weakness and muscle loss. This study will be done to measure the changes in muscle
      size and strength as a result of each patient's illness
An optional portion of the study is available to help determine if moving the leg repeatedly
      with a mechanical device helps prevent muscle loss and weakness. In this optional portion of
      the study, the subject would have a CPM (continuous passive motion) device attached to one of
      the subject's legs intermittently over the next three days. Without any effort from the
      subject , the machine would move the subjects leg back and forth (flexing at the hip and the
      knee) repeatedly.

      This machine is approved by the United States Food and Drug Administration (FDA) to treat
      patients after they have knee replacement surgery to help preserve the range of motion of the
      joint while minimizing risk of damage to the joint from more intensive exercise. The use of
      the device for this study is investigational.
observational model: Case-Only
time perspective: Prospective
measure: Quadriceps muscle cross sectional area change from day 0 to 7
time frame: seven days
description: Serial measures of quadriceps muscle by non-invasive ultrasound on Day of enrollment and Day 7 after enrollment
arm group label: CPM device
description: a CPM (continuous passive motion) device attached to one of your legs intermittently over the next three days.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naeem A Ali, MD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Naeem Ali, MD
investigator title: Medical Director, Medical Intensive Care Unit (MICU);
mesh term: Sepsis
mesh term: Toxemia
mesh term: Respiratory Insufficiency
mesh term: Muscular Atrophy
mesh term: Atrophy