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/NCT05998902</url>
    </required_header>
    <id_info>
      <org_study_id>XJLL-KY-20222214</org_study_id>
      <nct_id>NCT05998902</nct_id>
    </id_info>
    <brief_title>Optimizing Early Nutrition Support in Severe Stroke-2</brief_title>
    <official_title>Trophic Enteral Feeding Combined With Supplemental Parenteral Nutrition Treatment in Patients With Severe Stroke (OPENS-2): a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wen Jiang-3</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Tang-Du Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xi'an Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xi'an Gaoxin Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Xi'an Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xi'an No.3 Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First People's Hospital of Xianyang</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Second Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>PLA 960 Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Daping Hospital, The Third Military Medical University (Army Medical University)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Second Affiliated Hospital of Guangzhou University of Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Hospital Affiliated to Zhengzhou University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gansu Provincial Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Hospital of Changsha City</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shaanxi Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Yulin No.2 Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Yulin No.1 Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xijing Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Xijing Hospital</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>
        Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke&#xD;
        infections, in general, are associated with less favorable neurologic outcomes. Aspiration is&#xD;
        one of the most feared complications of enteral nutrition and can lead to the occurrence of&#xD;
        pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as&#xD;
        the reduced level of consciousness, inability to protect the airway and so on. The purpose of&#xD;
        this study is to explore the ideal nutrition support strategy for patient with acute severe&#xD;
        stroke to help reduce the incidence of PSP and improve the prognosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As one of the most common complication of stroke, some studies showed that post-stroke&#xD;
        pneumonia (PSP) in stroke patients requiring intensive care is associated with an increase of&#xD;
        ICU length of stay and hospital mortality and poorer functional outcomes in survivors. The&#xD;
        peak period of PSP is within the first week after stroke. Aspiration and poor nutritional&#xD;
        status are important factors leading to pneumonia in stroke patients. Compared with full&#xD;
        enteral nutrition (EN), initial trophic enteral feeding was associated with less&#xD;
        gastrointestinal intolerance and could reduce the rate of regurgitation. However, trophic&#xD;
        enteral feeding could not meet the daily caloric needs and hypocaloric enteral nutrition&#xD;
        might be associated with increased mortality. This study is designed to explore whether&#xD;
        initial trophic enteral nutrition combined with supplemental parenteral nutrition (SPN) can&#xD;
        help reduce the incidence of PSP and improve the prognosis in severe patients with stroke.&#xD;
  &#xD;
        This study will enroll 546 severe stroke patients who meet the inclusion criteria. Upon&#xD;
        admission to the ICU, patients will be randomly assigned at a 1:1 ratio into groups of full&#xD;
        enteral feeding (controlled) and trophic enteral feeding combined with supplemental&#xD;
        parenteral feeding (experimented) for 7 days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</primary_completion_date>
    <phase>Phase 3</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>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of post stroke pneumonia</measure>
      <time_frame>up to 7 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>The time from randomisation to the onset of the post stroke pneumonia</measure>
      <time_frame>up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily calorie delivery</measure>
      <time_frame>up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily protein delivery</measure>
      <time_frame>up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin dosage</measure>
      <time_frame>up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of gastrointestinal complications</measure>
      <time_frame>up to 7 days</time_frame>
      <description>Vomiting, diarrhea, gastric retention, gastrointestinal bleeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The use of prokinetic agents</measure>
      <time_frame>up to 7 days</time_frame>
      <description>The usage rate of prokinetic agents</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The occurrence of infections</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>The rate and onset time of infections from randomisation to ICU discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The length of ICU stay</measure>
      <time_frame>1 day of ICU discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>from randomisation to all cause death during ICU stay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The All-cause mortality rate</measure>
      <time_frame>28 days after enrollment</time_frame>
      <description>from randomisation to all cause death at 28 days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac failure</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>The incidence of cardiac failure from randomisation to ICU discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tracheotomy</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>The incidence of tracheotomy from randomisation to ICU discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mechanical ventilation</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>The incidence of mechanical ventilation from randomisation to ICU discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Continuous renal replacement therapy</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>The incidence of continuous renal replacement therapy from randomisation to ICU discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The use of vasoactive agents</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>The usage rate of vasoactive agents from randomisation to ICU discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Deep venous thrombosis</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>The incidence of deep venous thrombosis from randomisation to ICU discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The score of National Institute of Health stroke scale at ICU discharge</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>National Institute of Health stroke scale, with scores ranging from 0 (normal function) to 42 (functional impairment) was used to evaluate the impairment caused by a stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glasgow Coma Scale at ICU discharge</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>Glasgow Coma Scale,with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>modified Rankin scale at ICU discharge</measure>
      <time_frame>1 day of ICU discharge</time_frame>
      <description>modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>modified Rankin scale</measure>
      <time_frame>90 days after enrollment</time_frame>
      <description>modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">546</enrollment>
    <condition>Severe Stroke</condition>
    <condition>Acute Stroke</condition>
    <condition>Dysphagia</condition>
    <arm_group>
      <arm_group_label>Full enteral feeding</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Trophic enteral feeding combined with supplemental parenteral nutrition</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Trophic enteral feeding combined with supplemental parenteral nutrition</intervention_name>
      <description>The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Patients will receive the trophic enteral feeding with a caloric target of 500kcal/d (20-35ml/h), and the remaining calories are supplemented by parenteral nutrition. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.</description>
      <arm_group_label>Trophic enteral feeding combined with supplemental parenteral nutrition</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Full enteral feeding</intervention_name>
      <description>The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day. Enteral nutrition is given through nasogastric tube or nasointestinal tube.</description>
      <arm_group_label>Full enteral feeding</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age≥18 years&#xD;
  &#xD;
            2. Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)&#xD;
  &#xD;
            3. The randomized nutritional treatment could be initiated up to 72 hours after symptom&#xD;
               onset.&#xD;
  &#xD;
            4. Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of&#xD;
               consciousness.&#xD;
  &#xD;
            5. Plan to receive nutritional support treatment for at least 7 days.&#xD;
  &#xD;
            6. Informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Receiving parenteral nutrition support&#xD;
  &#xD;
            2. Contraindications of enteral nutrition&#xD;
  &#xD;
            3. Complicated with the disease which only have life expectancy &lt; 7 days&#xD;
  &#xD;
            4. Admission with infection signs&#xD;
  &#xD;
            5. Dementia or severe disability (mRS&gt;4) before stroke&#xD;
  &#xD;
            6. Antibiotics were used within the previous 7 days&#xD;
  &#xD;
            7. Subarachnoid hemorrhage, cerebral arteriovenous malformation&#xD;
  &#xD;
            8. Presence of coexisting medical conditions that could interfere with outcome assessment&#xD;
               and/or follow-up (a. advanced cancer; b. severe pulmonary dysfunction [forced&#xD;
               expiratory volume in 1 second &lt; 50% or/and moderate to severe acute lung injury&#xD;
               (PaO2/FiO2)&lt;200mmHg]; c. cardiac insufficiency (NYHA class &gt; I; cardiac structural&#xD;
               and/or functional abnormalities such as EF&lt; 50%, abnormal cardiac chamber enlargement,&#xD;
               moderate/severe ventricular hypertrophy, or moderate/severe valvular stenosis); d.&#xD;
               Severe liver failure [Child-Pugh score≥7]; e. Severe renal failure [glomerular&#xD;
               filtration rate ≤30mL/min or serum creatinine ≥4mg/dL]&#xD;
  &#xD;
            9. Currently participating in other clinical trial&#xD;
  &#xD;
           10. Pregnant woman&#xD;
  &#xD;
           11. Patient who is considered highly likely not to adhere to the study treatment or&#xD;
               follow-up protocol.&#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_contact>
      <last_name>Wen Jiang, Ph.D</last_name>
      <phone>86-029-84771319</phone>
      <email>jiangwen@fmmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xuan Wang, MD</last_name>
      <phone>86-029-84773664</phone>
      <email>786369892@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Daping Hospital, The Third Military Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Meng Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Gansu Provincal Central Hospital</name>
        <address>
          <city>Lanzhou</city>
          <state>Gansu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Rong Yin</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nanfang Hospital, Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Suyue Pan</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Guangzhou University of Chinese Medicine</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lixin Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>First Affiliated Hospital of Zhengzhou University</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wenjing Deng</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tongji Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Furong Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Changsha City</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hong Tan</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tangdu Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jun Guo, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xi'an Central Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhengli Di, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Neurology, Xijing Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wen Jiang, Ph.D</last_name>
        <phone>86-029-84771319</phone>
        <email>jiangwen@fmmu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shannxi Provincal People's Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hua Lv</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xi'an Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Bei Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xi'an Gaoxin Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yi Jia</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xi'an No.3 Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Mingze Chang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First People's Hospital of Xianyang</name>
        <address>
          <city>Xianyang</city>
          <state>Shaanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Liping Yu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yulin No.1 Hospital</name>
        <address>
          <city>Yulin</city>
          <state>Shaanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yongfeng Huang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yulin No.2 Hospital</name>
        <address>
          <city>Yulin</city>
          <state>Shaanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xue Li</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Qilu Hospital of Shangdong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qinzhou Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The PLA 960 Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Huaiqiang Hu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Hospital of Shandong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wei Shang</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Meisel A, Smith CJ. Prevention of stroke-associated pneumonia: where next? Lancet. 2015 Nov 7;386(10006):1802-4. doi: 10.1016/S0140-6736(15)00127-0. Epub 2015 Sep 3. No abstract available.</citation>
      <PMID>26343837</PMID>
    </reference>
    <reference>
      <citation>Wilson RD. Mortality and cost of pneumonia after stroke for different risk groups. J Stroke Cerebrovasc Dis. 2012 Jan;21(1):61-7. doi: 10.1016/j.jstrokecerebrovasdis.2010.05.002. Epub 2010 Jun 17.</citation>
      <PMID>22225864</PMID>
    </reference>
    <reference>
      <citation>Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, Di Napoli M, Kalra L, Langhorne P, Montaner J, Roffe C, Rudd AG, Tyrrell PJ, van de Beek D, Woodhead M, Meisel A, Smith CJ. How is pneumonia diagnosed in clinical stroke research? A systematic review and meta-analysis. Stroke. 2015 May;46(5):1202-9. doi: 10.1161/STROKEAHA.114.007843. Epub 2015 Apr 9.</citation>
      <PMID>25858238</PMID>
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    <reference>
      <citation>Suda S, Aoki J, Shimoyama T, Suzuki K, Sakamoto Y, Katano T, Okubo S, Nito C, Nishiyama Y, Mishina M, Kimura K. Stroke-associated infection independently predicts 3-month poor functional outcome and mortality. J Neurol. 2018 Feb;265(2):370-375. doi: 10.1007/s00415-017-8714-6. Epub 2017 Dec 16.</citation>
      <PMID>29249057</PMID>
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    <reference>
      <citation>Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S, Havard D, McFarlane M, McLauglin C, Randall M, Robson K, Scutt P, Smith C, Smithard D, Sprigg N, Warusevitane A, Watkins C, Woodhouse L, Bath PM. Post-stroke dysphagia: A review and design considerations for future trials. Int J Stroke. 2016 Jun;11(4):399-411. doi: 10.1177/1747493016639057. Epub 2016 Mar 22.</citation>
      <PMID>27006423</PMID>
    </reference>
    <reference>
      <citation>Westendorp WF, Nederkoorn PJ, Vermeij JD, Dijkgraaf MG, van de Beek D. Post-stroke infection: a systematic review and meta-analysis. BMC Neurol. 2011 Sep 20;11:110. doi: 10.1186/1471-2377-11-110.</citation>
      <PMID>21933425</PMID>
    </reference>
    <reference>
      <citation>Finlayson O, Kapral M, Hall R, Asllani E, Selchen D, Saposnik G; Canadian Stroke Network; Stroke Outcome Research Canada (SORCan) Working Group. Risk factors, inpatient care, and outcomes of pneumonia after ischemic stroke. Neurology. 2011 Oct 4;77(14):1338-45. doi: 10.1212/WNL.0b013e31823152b1. Epub 2011 Sep 21.</citation>
      <PMID>21940613</PMID>
    </reference>
    <reference>
      <citation>de Montmollin E, Ruckly S, Schwebel C, Philippart F, Adrie C, Mariotte E, Marcotte G, Cohen Y, Sztrymf B, da Silva D, Bruneel F, Gainnier M, Garrouste-Orgeas M, Sonneville R, Timsit JF; OUTCOMEREA Study Group. Pneumonia in acute ischemic stroke patients requiring invasive ventilation: Impact on short and long-term outcomes. J Infect. 2019 Sep;79(3):220-227. doi: 10.1016/j.jinf.2019.06.012. Epub 2019 Jun 22.</citation>
      <PMID>31238051</PMID>
    </reference>
    <reference>
      <citation>Suntrup-Krueger S, Kemmling A, Warnecke T, Hamacher C, Oelenberg S, Niederstadt T, Heindel W, Wiendl H, Dziewas R. The impact of lesion location on dysphagia incidence, pattern and complications in acute stroke. Part 2: Oropharyngeal residue, swallow and cough response, and pneumonia. Eur J Neurol. 2017 Jun;24(6):867-874. doi: 10.1111/ene.13307. Epub 2017 Apr 27.</citation>
      <PMID>28449405</PMID>
    </reference>
    <reference>
      <citation>Al-Khaled M. The multifactorial etiology of stroke-associated pneumonia. J Neurol Sci. 2019 May 15;400:30-31. doi: 10.1016/j.jns.2019.02.042. Epub 2019 Mar 12. No abstract available.</citation>
      <PMID>30884370</PMID>
    </reference>
    <reference>
      <citation>McClave SA, DeMeo MT, DeLegge MH, DiSario JA, Heyland DK, Maloney JP, Metheny NA, Moore FA, Scolapio JS, Spain DA, Zaloga GP. North American Summit on Aspiration in the Critically Ill Patient: consensus statement. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6 Suppl):S80-5. doi: 10.1177/014860710202600613.</citation>
      <PMID>12405628</PMID>
    </reference>
    <reference>
      <citation>Jabbar A, Chang WK, Dryden GW, McClave SA. Gut immunology and the differential response to feeding and starvation. Nutr Clin Pract. 2003 Dec;18(6):461-82. doi: 10.1177/0115426503018006461.</citation>
      <PMID>16215082</PMID>
    </reference>
    <reference>
      <citation>Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.</citation>
      <PMID>30348463</PMID>
    </reference>
    <reference>
      <citation>Uozumi M, Sanui M, Komuro T, Iizuka Y, Kamio T, Koyama H, Mouri H, Masuyama T, Ono K, Lefor AK. Interruption of enteral nutrition in the intensive care unit: a single-center survey. J Intensive Care. 2017 Aug 4;5:52. doi: 10.1186/s40560-017-0245-9. eCollection 2017.</citation>
      <PMID>28794882</PMID>
    </reference>
    <reference>
      <citation>Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.</citation>
      <PMID>25271389</PMID>
    </reference>
    <reference>
      <citation>Altintas ND, Aydin K, Turkoglu MA, Abbasoglu O, Topeli A. Effect of enteral versus parenteral nutrition on outcome of medical patients requiring mechanical ventilation. Nutr Clin Pract. 2011 Jun;26(3):322-9. doi: 10.1177/0884533611405790. Epub 2011 Apr 29.</citation>
      <PMID>21531737</PMID>
    </reference>
    <reference>
      <citation>Reignier J, Boisrame-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guerin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thevenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.</citation>
      <PMID>29128300</PMID>
    </reference>
    <reference>
      <citation>Compher C, Bingham AL, McCall M, Patel J, Rice TW, Braunschweig C, McKeever L. Guidelines for the provision of nutrition support therapy in the adult critically ill patient: The American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2022 Jan;46(1):12-41. doi: 10.1002/jpen.2267. Epub 2022 Jan 3. Erratum In: JPEN J Parenter Enteral Nutr. 2022 Aug;46(6):1458-1459.</citation>
      <PMID>34784064</PMID>
    </reference>
    <reference>
      <citation>Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.</citation>
      <PMID>23218813</PMID>
    </reference>
    <reference>
      <citation>Shi J, Wei L, Huang R, Liao L. Effect of combined parenteral and enteral nutrition versus enteral nutrition alone for critically ill patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Oct;97(41):e11874. doi: 10.1097/MD.0000000000011874.</citation>
      <PMID>30313021</PMID>
    </reference>
    <reference>
      <citation>National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.</citation>
      <PMID>22307571</PMID>
    </reference>
    <reference>
      <citation>Zhao J, Yuan F, Song C, Yin R, Chang M, Zhang W, Zhang B, Yu L, Jia Y, Ma Y, Song Y, Wang C, Song C, Wang X, Shang L, Yang F, Jiang W; OPENS Trial Investigators. Safety and efficacy of three enteral feeding strategies in patients with severe stroke in China (OPENS): a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2022 Apr;21(4):319-328. doi: 10.1016/S1474-4422(22)00010-2. Epub 2022 Feb 24.</citation>
      <PMID>35219379</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Xijing Hospital</investigator_affiliation>
      <investigator_full_name>Wen Jiang-3</investigator_full_name>
      <investigator_title>Head of Neurology</investigator_title>
    </responsible_party>
    <keyword>Severe Stroke</keyword>
    <keyword>Acute Stroke</keyword>
    <keyword>Dysphagia</keyword>
    <keyword>supplemental parenteral nutrition</keyword>
    <keyword>trophic feeding</keyword>
    <keyword>pneumonia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deglutition Disorders</mesh_term>
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05998902
  org study id: XJLL-KY-20222214
  nct id: NCT05998902
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  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke
        infections, in general, are associated with less favorable neurologic outcomes. Aspiration is
        one of the most feared complications of enteral nutrition and can lead to the occurrence of
        pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as
        the reduced level of consciousness, inability to protect the airway and so on. The purpose of
        this study is to explore the ideal nutrition support strategy for patient with acute severe
        stroke to help reduce the incidence of PSP and improve the prognosis.
  As one of the most common complication of stroke, some studies showed that post-stroke
        pneumonia (PSP) in stroke patients requiring intensive care is associated with an increase of
        ICU length of stay and hospital mortality and poorer functional outcomes in survivors. The
        peak period of PSP is within the first week after stroke. Aspiration and poor nutritional
        status are important factors leading to pneumonia in stroke patients. Compared with full
        enteral nutrition (EN), initial trophic enteral feeding was associated with less
        gastrointestinal intolerance and could reduce the rate of regurgitation. However, trophic
        enteral feeding could not meet the daily caloric needs and hypocaloric enteral nutrition
        might be associated with increased mortality. This study is designed to explore whether
        initial trophic enteral nutrition combined with supplemental parenteral nutrition (SPN) can
        help reduce the incidence of PSP and improve the prognosis in severe patients with stroke.
  
        This study will enroll 546 severe stroke patients who meet the inclusion criteria. Upon
        admission to the ICU, patients will be randomly assigned at a 1:1 ratio into groups of full
        enteral feeding (controlled) and trophic enteral feeding combined with supplemental
        parenteral feeding (experimented) for 7 days.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Incidence of post stroke pneumonia
  time frame: up to 7 days
  measure: The time from randomisation to the onset of the post stroke pneumonia
  time frame: up to 7 days
  measure: Daily calorie delivery
  time frame: up to 7 days
  measure: Daily protein delivery
  time frame: up to 7 days
  measure: Insulin dosage
  time frame: up to 7 days
  measure: The incidence of gastrointestinal complications
  time frame: up to 7 days
  description: Vomiting, diarrhea, gastric retention, gastrointestinal bleeding
  measure: The use of prokinetic agents
  time frame: up to 7 days
  description: The usage rate of prokinetic agents
  measure: The occurrence of infections
  time frame: 1 day of ICU discharge
  description: The rate and onset time of infections from randomisation to ICU discharge
  measure: The length of ICU stay
  time frame: 1 day of ICU discharge
  measure: Mortality
  time frame: 1 day of ICU discharge
  description: from randomisation to all cause death during ICU stay.
  measure: The All-cause mortality rate
  time frame: 28 days after enrollment
  description: from randomisation to all cause death at 28 days
  measure: Cardiac failure
  time frame: 1 day of ICU discharge
  description: The incidence of cardiac failure from randomisation to ICU discharge
  measure: Tracheotomy
  time frame: 1 day of ICU discharge
  description: The incidence of tracheotomy from randomisation to ICU discharge
  measure: Mechanical ventilation
  time frame: 1 day of ICU discharge
  description: The incidence of mechanical ventilation from randomisation to ICU discharge
  measure: Continuous renal replacement therapy
  time frame: 1 day of ICU discharge
  description: The incidence of continuous renal replacement therapy from randomisation to ICU discharge
  measure: The use of vasoactive agents
  time frame: 1 day of ICU discharge
  description: The usage rate of vasoactive agents from randomisation to ICU discharge
  measure: Deep venous thrombosis
  time frame: 1 day of ICU discharge
  description: The incidence of deep venous thrombosis from randomisation to ICU discharge
  measure: The score of National Institute of Health stroke scale at ICU discharge
  time frame: 1 day of ICU discharge
  description: National Institute of Health stroke scale, with scores ranging from 0 (normal function) to 42 (functional impairment) was used to evaluate the impairment caused by a stroke.
  measure: Glasgow Coma Scale at ICU discharge
  time frame: 1 day of ICU discharge
  description: Glasgow Coma Scale,with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.
  measure: modified Rankin scale at ICU discharge
  time frame: 1 day of ICU discharge
  description: modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
  measure: modified Rankin scale
  time frame: 90 days after enrollment
  description: modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
  arm group label: Full enteral feeding
  arm group type: Active Comparator
  description: Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.
  arm group label: Trophic enteral feeding combined with supplemental parenteral nutrition
  arm group type: Experimental
  description: Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.
  intervention type: Procedure
  intervention name: Trophic enteral feeding combined with supplemental parenteral nutrition
  description: The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Patients will receive the trophic enteral feeding with a caloric target of 500kcal/d (20-35ml/h), and the remaining calories are supplemented by parenteral nutrition. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.
  arm group label: Trophic enteral feeding combined with supplemental parenteral nutrition
  intervention type: Procedure
  intervention name: Full enteral feeding
  description: The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day. Enteral nutrition is given through nasogastric tube or nasointestinal tube.
  arm group label: Full enteral feeding
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wen Jiang, Ph.D
  phone: 86-029-84771319
  email: jiangwen@fmmu.edu.cn
  last name: Xuan Wang, MD
  phone: 86-029-84773664
  email: 786369892@qq.com
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  country: China
  citation: Meisel A, Smith CJ. Prevention of stroke-associated pneumonia: where next? Lancet. 2015 Nov 7;386(10006):1802-4. doi: 10.1016/S0140-6736(15)00127-0. Epub 2015 Sep 3. No abstract available.
  PMID: 26343837
  citation: Wilson RD. Mortality and cost of pneumonia after stroke for different risk groups. J Stroke Cerebrovasc Dis. 2012 Jan;21(1):61-7. doi: 10.1016/j.jstrokecerebrovasdis.2010.05.002. Epub 2010 Jun 17.
  PMID: 22225864
  citation: Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, Di Napoli M, Kalra L, Langhorne P, Montaner J, Roffe C, Rudd AG, Tyrrell PJ, van de Beek D, Woodhead M, Meisel A, Smith CJ. How is pneumonia diagnosed in clinical stroke research? A systematic review and meta-analysis. Stroke. 2015 May;46(5):1202-9. doi: 10.1161/STROKEAHA.114.007843. Epub 2015 Apr 9.
  PMID: 25858238
  citation: Suda S, Aoki J, Shimoyama T, Suzuki K, Sakamoto Y, Katano T, Okubo S, Nito C, Nishiyama Y, Mishina M, Kimura K. Stroke-associated infection independently predicts 3-month poor functional outcome and mortality. J Neurol. 2018 Feb;265(2):370-375. doi: 10.1007/s00415-017-8714-6. Epub 2017 Dec 16.
  PMID: 29249057
  citation: Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S, Havard D, McFarlane M, McLauglin C, Randall M, Robson K, Scutt P, Smith C, Smithard D, Sprigg N, Warusevitane A, Watkins C, Woodhouse L, Bath PM. Post-stroke dysphagia: A review and design considerations for future trials. Int J Stroke. 2016 Jun;11(4):399-411. doi: 10.1177/1747493016639057. Epub 2016 Mar 22.
  PMID: 27006423
  citation: Westendorp WF, Nederkoorn PJ, Vermeij JD, Dijkgraaf MG, van de Beek D. Post-stroke infection: a systematic review and meta-analysis. BMC Neurol. 2011 Sep 20;11:110. doi: 10.1186/1471-2377-11-110.
  PMID: 21933425
  citation: Finlayson O, Kapral M, Hall R, Asllani E, Selchen D, Saposnik G; Canadian Stroke Network; Stroke Outcome Research Canada (SORCan) Working Group. Risk factors, inpatient care, and outcomes of pneumonia after ischemic stroke. Neurology. 2011 Oct 4;77(14):1338-45. doi: 10.1212/WNL.0b013e31823152b1. Epub 2011 Sep 21.
  PMID: 21940613
  citation: de Montmollin E, Ruckly S, Schwebel C, Philippart F, Adrie C, Mariotte E, Marcotte G, Cohen Y, Sztrymf B, da Silva D, Bruneel F, Gainnier M, Garrouste-Orgeas M, Sonneville R, Timsit JF; OUTCOMEREA Study Group. Pneumonia in acute ischemic stroke patients requiring invasive ventilation: Impact on short and long-term outcomes. J Infect. 2019 Sep;79(3):220-227. doi: 10.1016/j.jinf.2019.06.012. Epub 2019 Jun 22.
  PMID: 31238051
  citation: Suntrup-Krueger S, Kemmling A, Warnecke T, Hamacher C, Oelenberg S, Niederstadt T, Heindel W, Wiendl H, Dziewas R. The impact of lesion location on dysphagia incidence, pattern and complications in acute stroke. Part 2: Oropharyngeal residue, swallow and cough response, and pneumonia. Eur J Neurol. 2017 Jun;24(6):867-874. doi: 10.1111/ene.13307. Epub 2017 Apr 27.
  PMID: 28449405
  citation: Al-Khaled M. The multifactorial etiology of stroke-associated pneumonia. J Neurol Sci. 2019 May 15;400:30-31. doi: 10.1016/j.jns.2019.02.042. Epub 2019 Mar 12. No abstract available.
  PMID: 30884370
  citation: McClave SA, DeMeo MT, DeLegge MH, DiSario JA, Heyland DK, Maloney JP, Metheny NA, Moore FA, Scolapio JS, Spain DA, Zaloga GP. North American Summit on Aspiration in the Critically Ill Patient: consensus statement. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6 Suppl):S80-5. doi: 10.1177/014860710202600613.
  PMID: 12405628
  citation: Jabbar A, Chang WK, Dryden GW, McClave SA. Gut immunology and the differential response to feeding and starvation. Nutr Clin Pract. 2003 Dec;18(6):461-82. doi: 10.1177/0115426503018006461.
  PMID: 16215082
  citation: Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.
  PMID: 30348463
  citation: Uozumi M, Sanui M, Komuro T, Iizuka Y, Kamio T, Koyama H, Mouri H, Masuyama T, Ono K, Lefor AK. Interruption of enteral nutrition in the intensive care unit: a single-center survey. J Intensive Care. 2017 Aug 4;5:52. doi: 10.1186/s40560-017-0245-9. eCollection 2017.
  PMID: 28794882
  citation: Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.
  PMID: 25271389
  citation: Altintas ND, Aydin K, Turkoglu MA, Abbasoglu O, Topeli A. Effect of enteral versus parenteral nutrition on outcome of medical patients requiring mechanical ventilation. Nutr Clin Pract. 2011 Jun;26(3):322-9. doi: 10.1177/0884533611405790. Epub 2011 Apr 29.
  PMID: 21531737
  citation: Reignier J, Boisrame-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guerin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thevenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.
  PMID: 29128300
  citation: Compher C, Bingham AL, McCall M, Patel J, Rice TW, Braunschweig C, McKeever L. Guidelines for the provision of nutrition support therapy in the adult critically ill patient: The American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2022 Jan;46(1):12-41. doi: 10.1002/jpen.2267. Epub 2022 Jan 3. Erratum In: JPEN J Parenter Enteral Nutr. 2022 Aug;46(6):1458-1459.
  PMID: 34784064
  citation: Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.
  PMID: 23218813
  citation: Shi J, Wei L, Huang R, Liao L. Effect of combined parenteral and enteral nutrition versus enteral nutrition alone for critically ill patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Oct;97(41):e11874. doi: 10.1097/MD.0000000000011874.
  PMID: 30313021
  citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
  PMID: 22307571
  citation: Zhao J, Yuan F, Song C, Yin R, Chang M, Zhang W, Zhang B, Yu L, Jia Y, Ma Y, Song Y, Wang C, Song C, Wang X, Shang L, Yang F, Jiang W; OPENS Trial Investigators. Safety and efficacy of three enteral feeding strategies in patients with severe stroke in China (OPENS): a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2022 Apr;21(4):319-328. doi: 10.1016/S1474-4422(22)00010-2. Epub 2022 Feb 24.
  PMID: 35219379
  responsible party type: Sponsor-Investigator
  investigator affiliation: Xijing Hospital
  investigator full name: Wen Jiang-3
  investigator title: Head of Neurology
  mesh term: Deglutition Disorders
  mesh term: Stroke
  sharing ipd: No