<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/NCT03038906</url>
  </required_header>
  <id_info>
    <org_study_id>PRIMROSE</org_study_id>
    <nct_id>NCT03038906</nct_id>
  </id_info>
  <brief_title>Effect of Randomization to Neuromuscular Blockade on Physical Functional Impairment and Recovery in ARDS</brief_title>
  <acronym>PRIMROSE</acronym>
  <official_title>Effect of Randomization to Neuromuscular Blockade on Physical Functional Impairment and Recovery in ARDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed work will determine the effect of neuromuscular blockade on physical function&#xD;
      and recovery in patients with ARDS. The investigators will conduct a prospective ancillary&#xD;
      study at five PETAL clinical centers that will evaluate the neuromuscular structure and&#xD;
      function of ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) patients during and&#xD;
      after critical illness, including in-person assessments at 6 months after hospital discharge.&#xD;
      The investigators hypothesize that patients randomized to NMB will have an increase in&#xD;
      ICU-acquired neuromuscular dysfunction during and after critical illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will assess this dysfunction in different ways, appropriate for patients'&#xD;
      stage of critical illness and anticipated recovery. During critical illness, the&#xD;
      investigators will use nerve conduction studies (NCS) to assess nerve and muscle function,&#xD;
      identifying presence of early neuromyopathy (primary outcome, Aim 1). Additional early&#xD;
      assessments will include bedside ultrasound to determine muscle mass and echogenicity,&#xD;
      indices of atrophy and loss of muscle architecture. Later in acute hospitalization as&#xD;
      patients are able to participate in testing, the investigators will use hand grip dynamometry&#xD;
      to assess muscle strength (primary outcome, Aim 2). Additional assessments at this time will&#xD;
      be hand held dynamometry to determine proximal muscle strength, dual energy x-ray&#xD;
      absorptiometry (DEXA) and repeat ultrasound to evaluate muscle mass, and short physical&#xD;
      performance battery (SPPB) to assess activity. After hospital discharge-at 6 months after&#xD;
      ARDS-the investigators will assess activity in-person using the SPPB (primary outcome, Aim&#xD;
      3). Additional post-hospital assessments include detailed evaluation of healthcare&#xD;
      utilization, six minute walk testing (6MWT) to determine endurance, and repetition of&#xD;
      previous assessments of muscle structure, function and strength to provide novel, detailed&#xD;
      information of recovery process.&#xD;
&#xD;
      Each aim tests a distinct hypothesis of the effect of randomization to NMB on ICU-acquired&#xD;
      neuromuscular dysfunction, investigating different time points and aspects of physical&#xD;
      function, so aims are not interdependent. For example, it is plausible that the direct&#xD;
      toxicity of NMB on muscle will lead to early evidence of neuromyopathy, manifest as reduced&#xD;
      muscle depolarization amplitudes with nerve stimulation. But if NMB attenuates lung injury,&#xD;
      strength may be improved by hospital discharge, despite early injury to muscle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Neuromyopathy</measure>
    <time_frame>Through 6 months after hospital discharge</time_frame>
    <description>The investigators are assessing neuromyopathy with electrophysiologic testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Function and Strength</measure>
    <time_frame>Through 6 months after hospital discharge</time_frame>
    <description>The investigators are assessing muscle strength with handgrip and handheld dynamometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Recovery and Healthcare Utilization</measure>
    <time_frame>6 months post ARDS</time_frame>
    <description>The investigators are assessing physical recovery with the short physical performance battery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">290</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Neuromyopathies</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Patients enrolling in NHLBI PETAL Network ROSE study of cisatracurium for moderate/severe ARDS at participating centers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects enrolled in the PETAL Network's ROSE (Reevaluation of Systemic Early Neuromuscular&#xD;
        Blockade) Study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be enrolled in the PETAL Network's ROSE study&#xD;
&#xD;
          -  Patients must have at least one complete leg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complete spinal cord injury with deficits at level T1 or above&#xD;
&#xD;
          -  Severe peripheral neuromuscular disease (specifically motor neuron disease (ALS) or&#xD;
             acute Guillain-Barre Syndrome)&#xD;
&#xD;
          -  Inability to obtain informed consent&#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>Catherine Hough, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catherine Hough, MD</last_name>
    <phone>2067443356</phone>
  </overall_contact>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Gundel, RD</last_name>
      <phone>206-744-7720</phone>
      <email>sgundel@uw.edu</email>
    </contact>
    <investigator>
      <last_name>Catherine L Hough, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Theodore J Iwashyna, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marc Moss, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel C Files, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter C Hou, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 29, 2017</last_update_submitted>
  <last_update_submitted_qc>January 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Catherine Hough</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</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/NCT03038906
org study id: PRIMROSE
nct id: NCT03038906
lead sponsor: 
has dmc: No
The proposed work will determine the effect of neuromuscular blockade on physical function
      and recovery in patients with ARDS. The investigators will conduct a prospective ancillary
      study at five PETAL clinical centers that will evaluate the neuromuscular structure and
      function of ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) patients during and
      after critical illness, including in-person assessments at 6 months after hospital discharge.
      The investigators hypothesize that patients randomized to NMB will have an increase in
      ICU-acquired neuromuscular dysfunction during and after critical illness.
The investigators will assess this dysfunction in different ways, appropriate for patients'
      stage of critical illness and anticipated recovery. During critical illness, the
      investigators will use nerve conduction studies (NCS) to assess nerve and muscle function,
      identifying presence of early neuromyopathy (primary outcome, Aim 1). Additional early
      assessments will include bedside ultrasound to determine muscle mass and echogenicity,
      indices of atrophy and loss of muscle architecture. Later in acute hospitalization as
      patients are able to participate in testing, the investigators will use hand grip dynamometry
      to assess muscle strength (primary outcome, Aim 2). Additional assessments at this time will
      be hand held dynamometry to determine proximal muscle strength, dual energy x-ray
      absorptiometry (DEXA) and repeat ultrasound to evaluate muscle mass, and short physical
      performance battery (SPPB) to assess activity. After hospital discharge-at 6 months after
      ARDS-the investigators will assess activity in-person using the SPPB (primary outcome, Aim
      3). Additional post-hospital assessments include detailed evaluation of healthcare
      utilization, six minute walk testing (6MWT) to determine endurance, and repetition of
      previous assessments of muscle structure, function and strength to provide novel, detailed
      information of recovery process.

      Each aim tests a distinct hypothesis of the effect of randomization to NMB on ICU-acquired
      neuromuscular dysfunction, investigating different time points and aspects of physical
      function, so aims are not interdependent. For example, it is plausible that the direct
      toxicity of NMB on muscle will lead to early evidence of neuromyopathy, manifest as reduced
      muscle depolarization amplitudes with nerve stimulation. But if NMB attenuates lung injury,
      strength may be improved by hospital discharge, despite early injury to muscle.
observational model: Cohort
time perspective: Prospective
measure: Neuromyopathy
time frame: Through 6 months after hospital discharge
description: The investigators are assessing neuromyopathy with electrophysiologic testing
measure: Muscle Function and Strength
time frame: Through 6 months after hospital discharge
description: The investigators are assessing muscle strength with handgrip and handheld dynamometry
measure: Physical Recovery and Healthcare Utilization
time frame: 6 months post ARDS
description: The investigators are assessing physical recovery with the short physical performance battery
arm group label: Cohort
description: Patients enrolling in NHLBI PETAL Network ROSE study of cisatracurium for moderate/severe ARDS at participating centers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine Hough, MD
role: Principal Investigator
affiliation: University of Washington
last name: Catherine Hough, MD
phone: 2067443356
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Catherine Hough
investigator title: Associate Professor of Medicine
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
sharing ipd: No