xml: <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/NCT06012201</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00003291</org_study_id>
      <nct_id>NCT06012201</nct_id>
    </id_info>
    <brief_title>Relationship Between Protein Intake and ICU Skeletal Muscle Weakness</brief_title>
    <official_title>Relationship Between Protein Intake and ICU Skeletal Muscle Weakness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tufts Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tufts Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Muscle wasting is a common finding in critically ill patients and is associated with adverse&#xD;
        outcomes. A good strategy for avoiding or decreasing muscle loss is adding adequate&#xD;
        quantities of protein to the nutritional therapy administered during the acute phase of the&#xD;
        disease during the ICU stay. The aim of this prospective study is to compare the effect of&#xD;
        different levels of protein enteral feeding on Rectus Femoris Muscle mass in mechanically&#xD;
        ventilated patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Muscle wasting is a common finding in critically ill patients and is associated with adverse&#xD;
        outcomes. Loss of mass and function of skeletal muscles start early in the first 24 h after&#xD;
        admission and may persist for years (post-ICU syndrome).&#xD;
  &#xD;
        It is a major cause of ICU-acquired muscle weakness and is associated with delayed weaning,&#xD;
        prolonged ICU and hospital stay, and is an independent predictor of 1-year mortality.&#xD;
  &#xD;
        Long-term muscle impairment affects the quality of life of ICU survivors as it is responsible&#xD;
        for physical, mental, and cognitive dysfunction and increases the costs of health care&#xD;
        services.&#xD;
  &#xD;
        Trauma is always associated with stress leading to multisystem alterations, changes in&#xD;
        macronutrient metabolism, as well as endocrine-metabolic activities, and immunological&#xD;
        responses.&#xD;
  &#xD;
        The stress response increases energy expenditure (EE) and the use of protein reserves. The&#xD;
        mobilization of these reserves is not a unidirectional catabolic process but it results in an&#xD;
        imbalance between protein synthesis and degradation depending on the magnitude of the trauma.&#xD;
  &#xD;
        The resulting negative protein balance may be associated with immunosuppression; poor wound&#xD;
        healing, muscle weakness, reduced survival, increasing length of hospitalization, and the&#xD;
        accompanying costs.&#xD;
  &#xD;
        Some authors consumed that a good strategy for avoidance or decreasing muscle loss is by&#xD;
        adding adequate quantities of protein to the nutritional therapy administered during the&#xD;
        acute phase of the disease during ICU stay.&#xD;
  &#xD;
        In this regard, the evaluation of skeletal muscles by B- mode Ultra-Sonography is an emerging&#xD;
        and reliable tool to assess muscle changes over time. It is a bedside technique, easy to use,&#xD;
        and inexpensive.&#xD;
  &#xD;
        Patients and methods:&#xD;
  &#xD;
        Patients will be randomly classified into 2 groups 1:1 according to their protein intake:&#xD;
  &#xD;
        Group I (low normal protein intake group):&#xD;
  &#xD;
        Patients in this group will receive protein at (0.8 -1.5 gm/kg/day).&#xD;
  &#xD;
        Group II (High normal protein intake group):&#xD;
  &#xD;
        Patients in this group will receive protein (1.6 - 2.2 gm/kg/day).&#xD;
  &#xD;
        For each patient on 1st day of admission, the following demographics and clinical data will&#xD;
        be recorded: age, weight, body mass index (BMI), Glasgow Coma Scale (GCS), blood levels of&#xD;
        albumin, total protein, and creatinine, then complete nutritional assessment is done for&#xD;
        every patient by modified NUTRIC risk assessment tool.&#xD;
  &#xD;
        Nutritional support This study will be carried out on you in the intensive care unit of tufts&#xD;
        medical center. Enteral feeding will be started as soon as the condition will be stable,&#xD;
        usually within 24 hours. The caloric requirement for you will be detected by indirect&#xD;
        calorimetry or calculation (30/35 Kcal/Kg/day) and will be supplied in the form of high&#xD;
        caloric Entral formula (1.5kcal/ml, 237ml contains 15.1 g protein) and the protein&#xD;
        supplementation will be completed by the addition of enteral supplemental protein&#xD;
        (beneprotein) as required to reach the target level of protein to reach at least minimum&#xD;
        protein requirement 0.8 grams per kilogram of body weight Tube feeding will be started at a&#xD;
        very low rate (10-20 ml/h) and the rate will be increased 25 ml every 6 hours until standard&#xD;
        requirements of caloric and protein intake is achieved. The patient's intolerance to feeding&#xD;
        is defined based on clinical signs (abdominal distention, vomiting, high gastric residual&#xD;
        volume ≥ 500 cc) and will be excluded from the final analysis.&#xD;
  &#xD;
        On 1st day of admission to the ICU, you will be intubated, ventilated, and sedated. Imaging&#xD;
        by ultrasound on subsequent days will be performed in patients who will be still intubated&#xD;
        and ventilated. An ultrasound (US) evaluation of the Rectus Femoris (RF) muscle will be&#xD;
        performed on day 0 (within 24 h from admission),1st, and 5th day.&#xD;
  &#xD;
        Assessment of Rectus Femoris muscle:&#xD;
  &#xD;
        On 1st day of admission, all patients will be intubated, ventilated, and sedated. Imaging on&#xD;
        subsequent days will be performed in patients who will be still intubated and ventilated.&#xD;
        Skeletal muscles will be evaluated by US scan, collecting both quantitative and qualitative&#xD;
        data.&#xD;
  &#xD;
        An ultrasound (US) evaluation of the Rectus Femoris(RF) muscle will be performed in all&#xD;
        patients on day 0 (within 24 h from trauma),1 st, and 5th day. We will use a US device with a&#xD;
        2- to 5-MHz linear probe. US settings (depth, gain, and focus) will be standardized for RF&#xD;
        examination. Excess contact gel will be applied so to minimize underlying soft tissue&#xD;
        distortion. The transducer will be placed perpendicular to the long axis of the muscle (i.e.,&#xD;
        perpendicular to the major axis of the limb), at 3/5 of the distance between the anterior&#xD;
        superior iliac spine and the superior border of patella (i.e., about 15 cm from the patella)&#xD;
        for the RF. The measurement points will be marked with indelible ink to ensure day-to-day&#xD;
        consistency and facilitate subsequent measurements. After freezing the US image, quantitative&#xD;
        parameters will be recorded for cross-sectional area (CSA) (computed from the perimetral&#xD;
        contour of the muscle section). The value of CSA is considered to be proportional to the&#xD;
        total mass of the skeletal muscle. We also will measure the Pennation angle of Rectus femoris&#xD;
        (The pennation angle is defined as the angle between muscle fibers and the deep fascia of the&#xD;
        muscle). Pennation angles will therefore be measured in the longitudinal ultrasound image as&#xD;
        the orientation of the fibers of the rectus femoris was almost parallel to their fascia.&#xD;
  &#xD;
        We also will record one qualitative parameter-echogenicity-that is expressed according to the&#xD;
        Heckmatt Scale. Increased echogenicity is usually regarded as an index of myofibers&#xD;
        depletion.&#xD;
  &#xD;
        Measurements and monitoring&#xD;
  &#xD;
          1. Demographic data e.g. age, sex, weight body mass index (BMI), Modified Nutric score.&#xD;
  &#xD;
          2. Quantitative parameters:&#xD;
  &#xD;
             Pennation angle, the cross-sectional area of rectus femoris muscle: at baseline then at&#xD;
             day 1 st, 5th after initiation of nutritional therapy.&#xD;
  &#xD;
          3. Qualitative parameter:&#xD;
  &#xD;
             Echogenicity by Heckmatt scale: at baseline then at baseline then at day 1 st, 5th after&#xD;
             initiation of nutritional therapy.&#xD;
  &#xD;
          4. Serum albumin and total protein at baseline then at day 1 st, and 5th after initiation&#xD;
             of nutritional therapy.&#xD;
  &#xD;
          5. Blood urea nitrogen, nitrogen balance at baseline then at day 1 st, 5th after initiation&#xD;
             of nutritional therapy.&#xD;
  &#xD;
          6. The length of mechanical ventilation and ICU stay will be estimated and compared in the&#xD;
             two groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>5 Days</target_duration>
    <primary_outcome>
      <measure>the percentage of reduction in the muscle mass measured by US.</measure>
      <time_frame>day 0 , 1, and 5 days of ICU admission</time_frame>
      <description>the percentage of muscle mass change compared to the other group</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pennation angle of rectus femoris muscle in degrees</measure>
      <time_frame>day 0 , 1, and 5 days of ICU admission</time_frame>
      <description>calculate the Pennation angle of rectus femoris compared to the other group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of mechanical ventilation and ICU stay in days</measure>
      <time_frame>until discharge or died</time_frame>
      <description>calculate the duration spent on the ventilator and days spent in the ICU reduced in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>age in years</measure>
      <time_frame>at the baseline day (0) of study</time_frame>
      <description>average age of each group in years and compared to each other</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>weight in kilograms</measure>
      <time_frame>at the baseline day (0) of study</time_frame>
      <description>weight of each patient in kilograms and compared to each other</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Mass index in Kilogram/meter square</measure>
      <time_frame>at the baseline day (0) of study</time_frame>
      <description>weight and height will be combined to report BMI in kg/m^2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sex predominance in each group</measure>
      <time_frame>at the baseline day (0) of study</time_frame>
      <description>sex predominance in each group and compare to each other</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>modified nutric score</measure>
      <time_frame>at the baseline day (0) of study</time_frame>
      <description>International score for evaluation of nutritional status of the each patient in each group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cross- sectional area in centimeter</measure>
      <time_frame>day 0 , 1, and 5 days of ICU admission</time_frame>
      <description>calculate the cross sectional area of rectus femoris compared to the other group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Echogenicity by Heckmatt scale</measure>
      <time_frame>day 0 , 1, and 5 days of ICU admission</time_frame>
      <description>it is a international scale to detect the echogenecity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum albumin and total protein in grams per deciliter</measure>
      <time_frame>day 0 , 1, and 5 days of ICU admission</time_frame>
      <description>measures Serum albumin and total protein for each patient in each group and compare between the two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood urea nitrogen in mg/dL</measure>
      <time_frame>at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy..</time_frame>
      <description>measures Blood urea nitrogen each patient in each group and compare between the two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>nitrogen balance in gram per day</measure>
      <time_frame>at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy.</time_frame>
      <description>measures nitrogen balance for each patient in each group and compare between the two groups</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Atrophy of Rectus Femoris Muscle (Physical Finding)</condition>
    <arm_group>
      <arm_group_label>low normal protein intake</arm_group_label>
      <description>the patient in this group will intake enteral protein feeding from 0.8- 1.5 gm /kg/day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>high normal protein intake</arm_group_label>
      <description>the patient in this group will intake enteral protein feeding from 1.6 - 2.2 gm /kg/day</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          all mechanically ventilated patients with a Glasgow Coma Scale ≤ 8 within 24 hours after&#xD;
          the injury. only well-nourished ( Modified Nutric -Score for Risk Screening = 0- 4),&#xD;
          previously healthy subjects&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients of both sexes, 18-50 years old with a Glasgow Coma Scale ≤ 8 and an&#xD;
               injury severity score (ISS&gt;15) were admitted to our ICU within 24 hours after the&#xD;
               injury. only well-nourished ( Modified Nutric -Score for Risk Screening = 0- 4),&#xD;
               previously healthy subjects will be recruited.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy, Patients with BMI ≥ 35,&#xD;
  &#xD;
            2. Vascular insufficiency or trauma to the lower limbs,&#xD;
  &#xD;
            3. History of neuromuscular diseases, Prolonged immobility prior to ICU admission,&#xD;
  &#xD;
            4. Comorbidities (renal, hepatic, cardiac disorders, chronic obstructive pulmonary&#xD;
               disease, and diabetic patient),&#xD;
  &#xD;
            5. Patients with malignant diseases or immune disorders,&#xD;
  &#xD;
            6. Prolonged corticosteroids (CS) or neuromuscular blocking agents (NMBA) use,&#xD;
  &#xD;
            7. ARDS patient (P/F ratio ≤ 200), Sepsis, Multiorgan failure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>PAVAN SEKHAR, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tufts Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>HANAN ELKALAWY, MD</last_name>
      <phone>8323750853</phone>
      <email>helkalawy@tuftsmedicalcenter.org</email>
    </overall_contact>
    <results_reference>
      <citation>Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189.</citation>
      <PMID>24410863</PMID>
    </results_reference>
    <results_reference>
      <citation>Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, Casaer MP, Meersseman P, Debaveye Y, Van Cromphaut S, Wouters PJ, Gosselink R, Van den Berghe G. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014 Aug 15;190(4):410-20. doi: 10.1164/rccm.201312-2257OC.</citation>
      <PMID>24825371</PMID>
    </results_reference>
    <results_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>
    </results_reference>
    <results_reference>
      <citation>Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.</citation>
      <PMID>24247473</PMID>
    </results_reference>
    <results_reference>
      <citation>Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.</citation>
      <PMID>21470008</PMID>
    </results_reference>
    <results_reference>
      <citation>Cunha HF, Rocha EE, Hissa M. Protein requirements, morbidity and mortality in critically ill patients: fundamentals and applications. Rev Bras Ter Intensiva. 2013 Mar;25(1):49-55. doi: 10.1590/s0103-507x2013000100010.</citation>
      <PMID>23887760</PMID>
    </results_reference>
    <results_reference>
      <citation>Ferrie S, Allman-Farinelli M, Daley M, Smith K. Protein Requirements in the Critically Ill: A Randomized Controlled Trial Using Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 2016 Aug;40(6):795-805. doi: 10.1177/0148607115618449. Epub 2015 Dec 3.</citation>
      <PMID>26635305</PMID>
    </results_reference>
    <results_reference>
      <citation>Mourtzakis M, Wischmeyer P. Bedside ultrasound measurement of skeletal muscle. Curr Opin Clin Nutr Metab Care. 2014 Sep;17(5):389-95. doi: 10.1097/MCO.0000000000000088.</citation>
      <PMID>25023190</PMID>
    </results_reference>
    <results_reference>
      <citation>de Vries MC, Koekkoek WK, Opdam MH, van Blokland D, van Zanten AR. Nutritional assessment of critically ill patients: validation of the modified NUTRIC score. Eur J Clin Nutr. 2018 Mar;72(3):428-435. doi: 10.1038/s41430-017-0008-7. Epub 2017 Nov 23.</citation>
      <PMID>29167575</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>January 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>protein- enteral- rectus femoris muscle</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscle Weakness</mesh_term>
      <mesh_term>Paresis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>We measure the rectus femoris muscle thickness,pennation angle, cross-sectional area, and echogenicity.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012201
  org study id: STUDY00003291
  nct id: NCT06012201
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Muscle wasting is a common finding in critically ill patients and is associated with adverse
        outcomes. A good strategy for avoiding or decreasing muscle loss is adding adequate
        quantities of protein to the nutritional therapy administered during the acute phase of the
        disease during the ICU stay. The aim of this prospective study is to compare the effect of
        different levels of protein enteral feeding on Rectus Femoris Muscle mass in mechanically
        ventilated patients.
  Muscle wasting is a common finding in critically ill patients and is associated with adverse
        outcomes. Loss of mass and function of skeletal muscles start early in the first 24 h after
        admission and may persist for years (post-ICU syndrome).
  
        It is a major cause of ICU-acquired muscle weakness and is associated with delayed weaning,
        prolonged ICU and hospital stay, and is an independent predictor of 1-year mortality.
  
        Long-term muscle impairment affects the quality of life of ICU survivors as it is responsible
        for physical, mental, and cognitive dysfunction and increases the costs of health care
        services.
  
        Trauma is always associated with stress leading to multisystem alterations, changes in
        macronutrient metabolism, as well as endocrine-metabolic activities, and immunological
        responses.
  
        The stress response increases energy expenditure (EE) and the use of protein reserves. The
        mobilization of these reserves is not a unidirectional catabolic process but it results in an
        imbalance between protein synthesis and degradation depending on the magnitude of the trauma.
  
        The resulting negative protein balance may be associated with immunosuppression; poor wound
        healing, muscle weakness, reduced survival, increasing length of hospitalization, and the
        accompanying costs.
  
        Some authors consumed that a good strategy for avoidance or decreasing muscle loss is by
        adding adequate quantities of protein to the nutritional therapy administered during the
        acute phase of the disease during ICU stay.
  
        In this regard, the evaluation of skeletal muscles by B- mode Ultra-Sonography is an emerging
        and reliable tool to assess muscle changes over time. It is a bedside technique, easy to use,
        and inexpensive.
  
        Patients and methods:
  
        Patients will be randomly classified into 2 groups 1:1 according to their protein intake:
  
        Group I (low normal protein intake group):
  
        Patients in this group will receive protein at (0.8 -1.5 gm/kg/day).
  
        Group II (High normal protein intake group):
  
        Patients in this group will receive protein (1.6 - 2.2 gm/kg/day).
  
        For each patient on 1st day of admission, the following demographics and clinical data will
        be recorded: age, weight, body mass index (BMI), Glasgow Coma Scale (GCS), blood levels of
        albumin, total protein, and creatinine, then complete nutritional assessment is done for
        every patient by modified NUTRIC risk assessment tool.
  
        Nutritional support This study will be carried out on you in the intensive care unit of tufts
        medical center. Enteral feeding will be started as soon as the condition will be stable,
        usually within 24 hours. The caloric requirement for you will be detected by indirect
        calorimetry or calculation (30/35 Kcal/Kg/day) and will be supplied in the form of high
        caloric Entral formula (1.5kcal/ml, 237ml contains 15.1 g protein) and the protein
        supplementation will be completed by the addition of enteral supplemental protein
        (beneprotein) as required to reach the target level of protein to reach at least minimum
        protein requirement 0.8 grams per kilogram of body weight Tube feeding will be started at a
        very low rate (10-20 ml/h) and the rate will be increased 25 ml every 6 hours until standard
        requirements of caloric and protein intake is achieved. The patient's intolerance to feeding
        is defined based on clinical signs (abdominal distention, vomiting, high gastric residual
        volume ≥ 500 cc) and will be excluded from the final analysis.
  
        On 1st day of admission to the ICU, you will be intubated, ventilated, and sedated. Imaging
        by ultrasound on subsequent days will be performed in patients who will be still intubated
        and ventilated. An ultrasound (US) evaluation of the Rectus Femoris (RF) muscle will be
        performed on day 0 (within 24 h from admission),1st, and 5th day.
  
        Assessment of Rectus Femoris muscle:
  
        On 1st day of admission, all patients will be intubated, ventilated, and sedated. Imaging on
        subsequent days will be performed in patients who will be still intubated and ventilated.
        Skeletal muscles will be evaluated by US scan, collecting both quantitative and qualitative
        data.
  
        An ultrasound (US) evaluation of the Rectus Femoris(RF) muscle will be performed in all
        patients on day 0 (within 24 h from trauma),1 st, and 5th day. We will use a US device with a
        2- to 5-MHz linear probe. US settings (depth, gain, and focus) will be standardized for RF
        examination. Excess contact gel will be applied so to minimize underlying soft tissue
        distortion. The transducer will be placed perpendicular to the long axis of the muscle (i.e.,
        perpendicular to the major axis of the limb), at 3/5 of the distance between the anterior
        superior iliac spine and the superior border of patella (i.e., about 15 cm from the patella)
        for the RF. The measurement points will be marked with indelible ink to ensure day-to-day
        consistency and facilitate subsequent measurements. After freezing the US image, quantitative
        parameters will be recorded for cross-sectional area (CSA) (computed from the perimetral
        contour of the muscle section). The value of CSA is considered to be proportional to the
        total mass of the skeletal muscle. We also will measure the Pennation angle of Rectus femoris
        (The pennation angle is defined as the angle between muscle fibers and the deep fascia of the
        muscle). Pennation angles will therefore be measured in the longitudinal ultrasound image as
        the orientation of the fibers of the rectus femoris was almost parallel to their fascia.
  
        We also will record one qualitative parameter-echogenicity-that is expressed according to the
        Heckmatt Scale. Increased echogenicity is usually regarded as an index of myofibers
        depletion.
  
        Measurements and monitoring
  
          1. Demographic data e.g. age, sex, weight body mass index (BMI), Modified Nutric score.
  
          2. Quantitative parameters:
  
             Pennation angle, the cross-sectional area of rectus femoris muscle: at baseline then at
             day 1 st, 5th after initiation of nutritional therapy.
  
          3. Qualitative parameter:
  
             Echogenicity by Heckmatt scale: at baseline then at baseline then at day 1 st, 5th after
             initiation of nutritional therapy.
  
          4. Serum albumin and total protein at baseline then at day 1 st, and 5th after initiation
             of nutritional therapy.
  
          5. Blood urea nitrogen, nitrogen balance at baseline then at day 1 st, 5th after initiation
             of nutritional therapy.
  
          6. The length of mechanical ventilation and ICU stay will be estimated and compared in the
             two groups.
  observational model: Cohort
  time perspective: Prospective
  measure: the percentage of reduction in the muscle mass measured by US.
  time frame: day 0 , 1, and 5 days of ICU admission
  description: the percentage of muscle mass change compared to the other group
  measure: Pennation angle of rectus femoris muscle in degrees
  time frame: day 0 , 1, and 5 days of ICU admission
  description: calculate the Pennation angle of rectus femoris compared to the other group
  measure: Length of mechanical ventilation and ICU stay in days
  time frame: until discharge or died
  description: calculate the duration spent on the ventilator and days spent in the ICU reduced in both groups
  measure: age in years
  time frame: at the baseline day (0) of study
  description: average age of each group in years and compared to each other
  measure: weight in kilograms
  time frame: at the baseline day (0) of study
  description: weight of each patient in kilograms and compared to each other
  measure: Body Mass index in Kilogram/meter square
  time frame: at the baseline day (0) of study
  description: weight and height will be combined to report BMI in kg/m^2
  measure: sex predominance in each group
  time frame: at the baseline day (0) of study
  description: sex predominance in each group and compare to each other
  measure: modified nutric score
  time frame: at the baseline day (0) of study
  description: International score for evaluation of nutritional status of the each patient in each group
  measure: cross- sectional area in centimeter
  time frame: day 0 , 1, and 5 days of ICU admission
  description: calculate the cross sectional area of rectus femoris compared to the other group
  measure: Echogenicity by Heckmatt scale
  time frame: day 0 , 1, and 5 days of ICU admission
  description: it is a international scale to detect the echogenecity
  measure: Serum albumin and total protein in grams per deciliter
  time frame: day 0 , 1, and 5 days of ICU admission
  description: measures Serum albumin and total protein for each patient in each group and compare between the two groups
  measure: Blood urea nitrogen in mg/dL
  time frame: at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy..
  description: measures Blood urea nitrogen each patient in each group and compare between the two groups
  measure: nitrogen balance in gram per day
  time frame: at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy.
  description: measures nitrogen balance for each patient in each group and compare between the two groups
  arm group label: low normal protein intake
  description: the patient in this group will intake enteral protein feeding from 0.8- 1.5 gm /kg/day
  arm group label: high normal protein intake
  description: the patient in this group will intake enteral protein feeding from 1.6 - 2.2 gm /kg/day
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: PAVAN SEKHAR, MD
  role: Principal Investigator
  affiliation: Tufts Medical Center
  last name: HANAN ELKALAWY, MD
  phone: 8323750853
  email: helkalawy@tuftsmedicalcenter.org
  citation: Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189.
  PMID: 24410863
  citation: Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, Casaer MP, Meersseman P, Debaveye Y, Van Cromphaut S, Wouters PJ, Gosselink R, Van den Berghe G. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014 Aug 15;190(4):410-20. doi: 10.1164/rccm.201312-2257OC.
  PMID: 24825371
  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: Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.
  PMID: 24247473
  citation: Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
  PMID: 21470008
  citation: Cunha HF, Rocha EE, Hissa M. Protein requirements, morbidity and mortality in critically ill patients: fundamentals and applications. Rev Bras Ter Intensiva. 2013 Mar;25(1):49-55. doi: 10.1590/s0103-507x2013000100010.
  PMID: 23887760
  citation: Ferrie S, Allman-Farinelli M, Daley M, Smith K. Protein Requirements in the Critically Ill: A Randomized Controlled Trial Using Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 2016 Aug;40(6):795-805. doi: 10.1177/0148607115618449. Epub 2015 Dec 3.
  PMID: 26635305
  citation: Mourtzakis M, Wischmeyer P. Bedside ultrasound measurement of skeletal muscle. Curr Opin Clin Nutr Metab Care. 2014 Sep;17(5):389-95. doi: 10.1097/MCO.0000000000000088.
  PMID: 25023190
  citation: de Vries MC, Koekkoek WK, Opdam MH, van Blokland D, van Zanten AR. Nutritional assessment of critically ill patients: validation of the modified NUTRIC score. Eur J Clin Nutr. 2018 Mar;72(3):428-435. doi: 10.1038/s41430-017-0008-7. Epub 2017 Nov 23.
  PMID: 29167575
  responsible party type: Sponsor
  mesh term: Muscle Weakness
  mesh term: Paresis
  sharing ipd: Undecided
  ipd description: We measure the rectus femoris muscle thickness,pennation angle, cross-sectional area, and echogenicity.