<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/NCT03825419</url>
  </required_header>
  <id_info>
    <org_study_id>MASS</org_study_id>
    <nct_id>NCT03825419</nct_id>
  </id_info>
  <brief_title>Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition (MASS)</brief_title>
  <acronym>MASS</acronym>
  <official_title>Muscle Assessment in Stroke Study (MASS): Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turkish Stroke Research and Clinical Trials Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinar CRO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Turkish Neurological Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Turkish Stroke Research and Clinical Trials Network</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>
      The degree of muscle loss over the course of inpatient stay will be evaluated in patients&#xD;
      with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units and&#xD;
      necessitating enteral nutrition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter, prospective observational study. The study period is 12 months.&#xD;
      There are no investigational products to be followed or used in the study.&#xD;
&#xD;
      Demographic data, stroke subtype, lesion localization, anthropometric measures will be&#xD;
      recorded. Muscle in three different anatomical sites will be measured by CT following&#xD;
      admission in patients included in the study.&#xD;
&#xD;
      For anthropometric measurements, height, body weight, body mass index, waist circumference,&#xD;
      triceps skin thickness and calf circumference values will be used.&#xD;
&#xD;
      The muscle mass will be measured from the paraspinal muscles at the L3 vertebra level and&#xD;
      from the muscles around the humerus and femur on the non-paralytic side of the extremities by&#xD;
      CT.&#xD;
&#xD;
      All patients will receive standard enteral nutritional support with a standardized calorie&#xD;
      and protein-based protocol recommended by international guidelines. The choice of the&#xD;
      commercial enteral product will be left to the investigator, without any encouragement or&#xD;
      restriction for use of any commercial product.&#xD;
&#xD;
      The enteral nutrition protocol will be implemented as follows;&#xD;
&#xD;
        -  Nasogastric or nasojejunal access&#xD;
&#xD;
        -  Continuous infusion&#xD;
&#xD;
        -  Targeted daily calories - 25-30 kcal / kg&#xD;
&#xD;
        -  Targeted daily protein - 1.2-1.5 gr / kg&#xD;
&#xD;
        -  20 ml / h initial infusion rate&#xD;
&#xD;
        -  Increase infusion rate by 10-20 ml / h in 8-12 hours&#xD;
&#xD;
        -  Targeted calorie-protein requirement will be reached at the end of 72 hours.&#xD;
&#xD;
      Patients will continue their routine follow-up in the neurology intensive care unit / stroke&#xD;
      unit / neurology department. Daily enteral nutrition dose, complications attributed to&#xD;
      enteral nutrition and systemic comorbidities will be recorded. Anthropometric measurements&#xD;
      and muscle mass measurements with CT at three different locations will be repeated at the end&#xD;
      of the second week (14 days ± 3 days) .&#xD;
&#xD;
      The study will evaluate whether or not muscle mass develops 14 days after acute ischemic&#xD;
      stroke. The end points of the study is deterioration of anthropometric measurements and loss&#xD;
      of muscle mass demonstrated by CT at follow up. The differences between patients with and&#xD;
      without muscle loss will be assessed from the the aspects of demographic characteristics,&#xD;
      ischemic stroke subtype, comorbidities and the success attained in reaching enteral&#xD;
      nutritional goals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Change in muscle mass</measure>
    <time_frame>14 days</time_frame>
    <description>Comparison of anthropometric measurements and CT based muscle mass measurements obtained at admission and at day 14 (± 3 days)</description>
  </primary_outcome>
  <enrollment type="Actual">125</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units for&#xD;
        whom enteral nutrition is indicated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients to be included in this study are required to meet all of the following inclusion&#xD;
        criteria:&#xD;
&#xD;
          -  Acute ischemic stroke&#xD;
&#xD;
          -  Admission within first 24 hours after symptom onset&#xD;
&#xD;
          -  Admission NIHSS score &gt; 8&#xD;
&#xD;
          -  Being unable to walk&#xD;
&#xD;
          -  Need for enteral tube feeding due to problems with consciousness or dysphagia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with any of the following exclusion criteria can not be included in the study:&#xD;
&#xD;
          -  Retained ability for oral feeding&#xD;
&#xD;
          -  Known muscle disease, neuropathy, neuromuscular junction disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Ankara University Faculty of Medicine</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gazi University Faculty Of Medicine</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Faculty of Medicine</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eskişehir Osmangazi Faculty of Medicine</name>
      <address>
        <city>Eskişehir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaziantep University Faculty of Medicine</name>
      <address>
        <city>Gaziantep</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>İstanbul Şişli Hamidiye Etfal Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokuz Eylül University Faculty of Medicine</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege University Faculty of Medicine</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>İzmir Katip Çelebi University Atatürk Training and Research Hospital</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ondokuz Mayıs University Faculty of Medicine</name>
      <address>
        <city>Samsun</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Shiraishi A, Yoshimura Y, Wakabayashi H, Tsuji Y. Prevalence of stroke-related sarcopenia and its association with poor oral status in post-acute stroke patients: Implications for oral sarcopenia. Clin Nutr. 2018 Feb;37(1):204-207. doi: 10.1016/j.clnu.2016.12.002. Epub 2016 Dec 10.</citation>
    <PMID>28017450</PMID>
  </reference>
  <reference>
    <citation>Scherbakov N, Sandek A, Doehner W. Stroke-related sarcopenia: specific characteristics. J Am Med Dir Assoc. 2015 Apr;16(4):272-6. doi: 10.1016/j.jamda.2014.12.007. Epub 2015 Feb 10.</citation>
    <PMID>25676847</PMID>
  </reference>
  <reference>
    <citation>Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].</citation>
    <PMID>24108501</PMID>
  </reference>
  <reference>
    <citation>Coelen RJ, Wiggers JK, Nio CY, Besselink MG, Busch OR, Gouma DJ, van Gulik TM. Preoperative computed tomography assessment of skeletal muscle mass is valuable in predicting outcomes following hepatectomy for perihilar cholangiocarcinoma. HPB (Oxford). 2015 Jun;17(6):520-8. doi: 10.1111/hpb.12394. Epub 2015 Feb 28.</citation>
    <PMID>25726722</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turkish Stroke Research and Clinical Trials Network</investigator_affiliation>
    <investigator_full_name>Ethem Murat Arsava</investigator_full_name>
    <investigator_title>Prof.Dr.</investigator_title>
  </responsible_party>
  <keyword>Stroke, Acute, Neurocritical Care, Nutrition, Sarcopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03825419
org study id: MASS
nct id: NCT03825419
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The degree of muscle loss over the course of inpatient stay will be evaluated in patients
      with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units and
      necessitating enteral nutrition.
This study is a multicenter, prospective observational study. The study period is 12 months.
      There are no investigational products to be followed or used in the study.

      Demographic data, stroke subtype, lesion localization, anthropometric measures will be
      recorded. Muscle in three different anatomical sites will be measured by CT following
      admission in patients included in the study.

      For anthropometric measurements, height, body weight, body mass index, waist circumference,
      triceps skin thickness and calf circumference values will be used.

      The muscle mass will be measured from the paraspinal muscles at the L3 vertebra level and
      from the muscles around the humerus and femur on the non-paralytic side of the extremities by
      CT.

      All patients will receive standard enteral nutritional support with a standardized calorie
      and protein-based protocol recommended by international guidelines. The choice of the
      commercial enteral product will be left to the investigator, without any encouragement or
      restriction for use of any commercial product.

      The enteral nutrition protocol will be implemented as follows;

        -  Nasogastric or nasojejunal access

        -  Continuous infusion

        -  Targeted daily calories - 25-30 kcal / kg

        -  Targeted daily protein - 1.2-1.5 gr / kg

        -  20 ml / h initial infusion rate

        -  Increase infusion rate by 10-20 ml / h in 8-12 hours

        -  Targeted calorie-protein requirement will be reached at the end of 72 hours.

      Patients will continue their routine follow-up in the neurology intensive care unit / stroke
      unit / neurology department. Daily enteral nutrition dose, complications attributed to
      enteral nutrition and systemic comorbidities will be recorded. Anthropometric measurements
      and muscle mass measurements with CT at three different locations will be repeated at the end
      of the second week (14 days ± 3 days) .

      The study will evaluate whether or not muscle mass develops 14 days after acute ischemic
      stroke. The end points of the study is deterioration of anthropometric measurements and loss
      of muscle mass demonstrated by CT at follow up. The differences between patients with and
      without muscle loss will be assessed from the the aspects of demographic characteristics,
      ischemic stroke subtype, comorbidities and the success attained in reaching enteral
      nutritional goals.
observational model: Cohort
time perspective: Prospective
measure: Change in muscle mass
time frame: 14 days
description: Comparison of anthropometric measurements and CT based muscle mass measurements obtained at admission and at day 14 (± 3 days)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Turkey
citation: Shiraishi A, Yoshimura Y, Wakabayashi H, Tsuji Y. Prevalence of stroke-related sarcopenia and its association with poor oral status in post-acute stroke patients: Implications for oral sarcopenia. Clin Nutr. 2018 Feb;37(1):204-207. doi: 10.1016/j.clnu.2016.12.002. Epub 2016 Dec 10.
PMID: 28017450
citation: Scherbakov N, Sandek A, Doehner W. Stroke-related sarcopenia: specific characteristics. J Am Med Dir Assoc. 2015 Apr;16(4):272-6. doi: 10.1016/j.jamda.2014.12.007. Epub 2015 Feb 10.
PMID: 25676847
citation: Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].
PMID: 24108501
citation: Coelen RJ, Wiggers JK, Nio CY, Besselink MG, Busch OR, Gouma DJ, van Gulik TM. Preoperative computed tomography assessment of skeletal muscle mass is valuable in predicting outcomes following hepatectomy for perihilar cholangiocarcinoma. HPB (Oxford). 2015 Jun;17(6):520-8. doi: 10.1111/hpb.12394. Epub 2015 Feb 28.
PMID: 25726722
responsible party type: Principal Investigator
investigator affiliation: Turkish Stroke Research and Clinical Trials Network
investigator full name: Ethem Murat Arsava
investigator title: Prof.Dr.
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: Undecided