<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/NCT03231540</url>
  </required_header>
  <id_info>
    <org_study_id>2016.101</org_study_id>
    <nct_id>NCT03231540</nct_id>
  </id_info>
  <brief_title>The PREServation of MUScle Function in Critically Ill Patients (PRESMUS)</brief_title>
  <acronym>PRESMUS</acronym>
  <official_title>Effect of Whey Protein-enriched Enteral Nutrition in Addition to Standardized Exercise Training on the PREServation of MUScle Function in Critically Ill Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of whey protein enriched enteral nutrition in addition to&#xD;
      exercise training on the preservation of muscle function in critically ill patients.&#xD;
&#xD;
      One half of patients receive whey protein enriched enteral nutrition with a protein intake of&#xD;
      1.5 g/kg/day and the other half of patients receive standard enteral nutrition with a protein&#xD;
      intake of 1 g/kg/day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Muscle wasting has an enormous impact on long-term physical performance and quality of life&#xD;
      of intensive care survivors. Limitation of muscle wasting might therefore improve physical&#xD;
      performance and quality of life. Data on high protein nutritional intake in addition to a&#xD;
      standardized exercise training program to prevent skeletal muscle wasting during critical&#xD;
      illness are lacking.&#xD;
&#xD;
      Objective: to determine whether early high protein intake, using an enteral whey protein&#xD;
      supplement, in addition to a standardized exercise training program and standard enteral&#xD;
      nutrition preserves: a) in vitro skeletal muscle function in critically ill patients during&#xD;
      the first week of intensive care unit (ICU) admission and b) short- and long-term in vivo&#xD;
      muscle function and mass, clinical outcomes and quality of life in critically ill patients.&#xD;
      Secondly, to determine whether high protein intake, in addition to standardized exercise and&#xD;
      standard enteral nutrition, increases muscle protein synthesis and attenuates activation of&#xD;
      the Ubiquitin-Proteasome pathway in critically ill patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>in vitro loss of skeletal muscle function</measure>
    <time_frame>day 1-3 and day 8-10</time_frame>
    <description>measured by contractility of of individual muscle fibers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>loss of muscle function</measure>
    <time_frame>day 1-3, day 8-10, day 28</time_frame>
    <description>Medical research council (MRC) sum score,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in body composition</measure>
    <time_frame>day 1-3, day 8-10, day 28</time_frame>
    <description>Bioelectrical impedance analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>loss of muscle mass</measure>
    <time_frame>day 1-3, day 8-10, day 28</time_frame>
    <description>Ultrasound (US) of the quadriceps femoris muscle and diaphragm, questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Short form (SF)- 36 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Critically Ill</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard enteral nutrition, with protein intake of 1g/kg/day; in addition to standardized exercise training</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey protein supplement</intervention_name>
    <description>Whey protein supplement to target protein intake of 1.5 g/kg/day</description>
    <arm_group_label>intervention group</arm_group_label>
    <other_name>Beneprotein Nestle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to the intensive care&#xD;
&#xD;
          -  Mechanically ventilated&#xD;
&#xD;
          -  Expected duration of ventilation of 72 hours&#xD;
&#xD;
          -  Expected to tolerate and require enteral nutrition for more than 72 hours&#xD;
&#xD;
          -  Sequential organ failure assessment (SOFA)-score&gt;6 on admission day&#xD;
&#xD;
          -  Written informed consent of patient or legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra-indication to enteral nutrition&#xD;
&#xD;
          -  Short bowel syndrome&#xD;
&#xD;
          -  Child C liver cirrhosis or acute liver failure&#xD;
&#xD;
          -  Dialysis dependency&#xD;
&#xD;
          -  Requiring other specific enteral nutrition for medical reason&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 35 kg/m2&#xD;
&#xD;
          -  Extensive treatment limitations&#xD;
&#xD;
          -  Disseminated malignancy&#xD;
&#xD;
          -  Haematological malignancy&#xD;
&#xD;
          -  Primary neuromuscular pathology&#xD;
&#xD;
          -  Chronic use of corticosteroids for &gt; 7 days before ICU admission&#xD;
&#xD;
          -  Contra-indication for muscle biopsy (need for uninterrupted systemic anticoagulation,&#xD;
             prothrombin time &gt;1.4 , Thrombocytes &lt;100).&#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>Sandra N Stapel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam UMC, location VUmc</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra N Stapel, MD</last_name>
    <email>s.stapel@vumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Monique Waard</last_name>
    <email>mc.dewaard@vumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VU Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Stapel, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>April 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>Sandra Stapel</investigator_full_name>
    <investigator_title>intensivist</investigator_title>
  </responsible_party>
  <keyword>Critical care</keyword>
  <keyword>nutrition</keyword>
  <keyword>whey protein</keyword>
  <keyword>mechanical ventilation</keyword>
  <keyword>muscle function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03231540
org study id: 2016.101
nct id: NCT03231540
lead sponsor: 
collaborator: 
has dmc: No
This study evaluates the effect of whey protein enriched enteral nutrition in addition to
      exercise training on the preservation of muscle function in critically ill patients.

      One half of patients receive whey protein enriched enteral nutrition with a protein intake of
      1.5 g/kg/day and the other half of patients receive standard enteral nutrition with a protein
      intake of 1 g/kg/day.
Muscle wasting has an enormous impact on long-term physical performance and quality of life
      of intensive care survivors. Limitation of muscle wasting might therefore improve physical
      performance and quality of life. Data on high protein nutritional intake in addition to a
      standardized exercise training program to prevent skeletal muscle wasting during critical
      illness are lacking.

      Objective: to determine whether early high protein intake, using an enteral whey protein
      supplement, in addition to a standardized exercise training program and standard enteral
      nutrition preserves: a) in vitro skeletal muscle function in critically ill patients during
      the first week of intensive care unit (ICU) admission and b) short- and long-term in vivo
      muscle function and mass, clinical outcomes and quality of life in critically ill patients.
      Secondly, to determine whether high protein intake, in addition to standardized exercise and
      standard enteral nutrition, increases muscle protein synthesis and attenuates activation of
      the Ubiquitin-Proteasome pathway in critically ill patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: in vitro loss of skeletal muscle function
time frame: day 1-3 and day 8-10
description: measured by contractility of of individual muscle fibers
measure: loss of muscle function
time frame: day 1-3, day 8-10, day 28
description: Medical research council (MRC) sum score,
measure: changes in body composition
time frame: day 1-3, day 8-10, day 28
description: Bioelectrical impedance analysis (BIA)
measure: loss of muscle mass
time frame: day 1-3, day 8-10, day 28
description: Ultrasound (US) of the quadriceps femoris muscle and diaphragm, questionnaires
measure: quality of life
time frame: 3 months
description: Short form (SF)- 36 questionnaire
arm group label: intervention group
arm group type: Experimental
description: whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training
arm group label: control group
arm group type: No Intervention
description: standard enteral nutrition, with protein intake of 1g/kg/day; in addition to standardized exercise training
intervention type: Dietary Supplement
intervention name: Whey protein supplement
description: Whey protein supplement to target protein intake of 1.5 g/kg/day
arm group label: intervention group
other name: Beneprotein Nestle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sandra N Stapel, MD
role: Principal Investigator
affiliation: Amsterdam UMC, location VUmc
last name: Sandra N Stapel, MD
email: s.stapel@vumc.nl
last name: Monique Waard
email: mc.dewaard@vumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: Sandra Stapel
investigator title: intensivist
mesh term: Critical Illness
sharing ipd: Undecided