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/NCT05971810</url>
    </required_header>
    <id_info>
      <org_study_id>I-23PJ953</org_study_id>
      <nct_id>NCT05971810</nct_id>
    </id_info>
    <brief_title>Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly</brief_title>
    <acronym>POINT</acronym>
    <official_title>Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fujian Provincial Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Second Hospital of Hebei Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shenzhen Qianhai Shekou Free Trade Zone Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ningbo No.2 Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking University International Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking Union Medical College 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>
        The goal of this multicenter randomized controlled trial is to explore the efficacy of&#xD;
        perioperative oral decontamination and immunonutrition supplement to prevent postoperative&#xD;
        pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac&#xD;
        operations. Participants will be either given immunonutrition supplement versus routine&#xD;
        nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly.&#xD;
        The two interventions will be compared with control groups separately regarding postoperative&#xD;
        pulmonary complications and other outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, multicenter, two-by-two factorial randomized controlled trial&#xD;
        evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine&#xD;
        decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac&#xD;
        surgeries will be recruited. Participants will be excluded if they have contraindication to&#xD;
        the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral&#xD;
        decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition&#xD;
        advice). The primary outcome is the incidence of postoperative pulmonary complications within&#xD;
        7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious&#xD;
        complications, comprehensive complication index, postoperative functional recovery, length of&#xD;
        hospital stay and hospital expense.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</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>Factorial Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>postoperative pulmonary complications</measure>
      <time_frame>within 7 days after surgery</time_frame>
      <description>composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>postoperative pneumonia</measure>
      <time_frame>within 7days and 30 days after surgery</time_frame>
      <description>defined according to the US Centers for Disease Control Definition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative pulmonary complications</measure>
      <time_frame>within 30 days after surgery</time_frame>
      <description>composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative infectious complications</measure>
      <time_frame>within 7days and 30 days after surgery</time_frame>
      <description>composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative complications</measure>
      <time_frame>within 7days and 30 days after surgery</time_frame>
      <description>defined using comprehensive complication index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative recovery</measure>
      <time_frame>within 7days and 30 days after surgery</time_frame>
      <description>assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hospitalization expenses</measure>
      <time_frame>upon hospital discharge, typically 1-2 weeks</time_frame>
      <description>total expense during the hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of hospital stay</measure>
      <time_frame>upon hospital discharge，typically 1-2 weeks</time_frame>
      <description>days of in hospital stay</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">592</enrollment>
    <condition>Postoperative Complications</condition>
    <condition>Pulmonary Complication</condition>
    <arm_group>
      <arm_group_label>Group A (immunonutrition and oral chlorhexidine decontamination, IN&amp;CD)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B (immunonutrition and routine oral care, IN&amp;RC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. For oral health care, they will receive routine oral care which is routine toothbrushing twice daily.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&amp;CD)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group D (routine nutrition advice and routine oral care, RN&amp;RC)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive routine oral care which is routine toothbrushing twice daily.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>immunonutrition supplement of ORAL IMPACT™</intervention_name>
      <description>For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.</description>
      <arm_group_label>Group A (immunonutrition and oral chlorhexidine decontamination, IN&amp;CD)</arm_group_label>
      <arm_group_label>Group B (immunonutrition and routine oral care, IN&amp;RC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>oral chlorhexidine decontamination</intervention_name>
      <description>For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.</description>
      <arm_group_label>Group A (immunonutrition and oral chlorhexidine decontamination, IN&amp;CD)</arm_group_label>
      <arm_group_label>Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&amp;CD)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. age≥65 years;&#xD;
  &#xD;
            2. undergoing major non-cardiac surgery;&#xD;
  &#xD;
            3. scheduled for general anesthesia and endotracheal intubation;&#xD;
  &#xD;
            4. American Society of Anesthesiologists (ASA) physical status classification I-IV;&#xD;
  &#xD;
            5. with intermediate to high risk of respiratory complications assessed by Assess&#xD;
               Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;&#xD;
  &#xD;
            6. informed consent obtained.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. emergency surgery;&#xD;
  &#xD;
            2. preoperative pneumonia;&#xD;
  &#xD;
            3. allergic to chlorhexidine;&#xD;
  &#xD;
            4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases,&#xD;
               taking immunosuppressant or immunoregulation medications, or with other&#xD;
               contraindication to immunonutrition supplementation;&#xD;
  &#xD;
            5. expected intervention of immunonutrition&lt;3 days.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yuguang Huang, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lu Che, Dr</last_name>
      <phone>69152020</phone>
      <email>tracymaobao@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Second Hospital of Hebei Medical University</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chaolei Liu</last_name>
        <email>verna521@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Peking</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lu Che, M.D</last_name>
        <email>tracymaobao@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>immunonutrition</keyword>
    <keyword>oral decontamination</keyword>
    <keyword>postoperative pulmonary complications</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postoperative Complications</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chlorhexidine</mesh_term>
    </intervention_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/NCT05971810
  org study id: I-23PJ953
  nct id: NCT05971810
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this multicenter randomized controlled trial is to explore the efficacy of
        perioperative oral decontamination and immunonutrition supplement to prevent postoperative
        pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac
        operations. Participants will be either given immunonutrition supplement versus routine
        nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly.
        The two interventions will be compared with control groups separately regarding postoperative
        pulmonary complications and other outcomes.
  This study is a prospective, multicenter, two-by-two factorial randomized controlled trial
        evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine
        decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac
        surgeries will be recruited. Participants will be excluded if they have contraindication to
        the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral
        decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition
        advice). The primary outcome is the incidence of postoperative pulmonary complications within
        7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious
        complications, comprehensive complication index, postoperative functional recovery, length of
        hospital stay and hospital expense.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Prevention
  masking: Double (Investigator, Outcomes Assessor)
  measure: postoperative pulmonary complications
  time frame: within 7 days after surgery
  description: composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.
  measure: postoperative pneumonia
  time frame: within 7days and 30 days after surgery
  description: defined according to the US Centers for Disease Control Definition
  measure: postoperative pulmonary complications
  time frame: within 30 days after surgery
  description: composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.
  measure: postoperative infectious complications
  time frame: within 7days and 30 days after surgery
  description: composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc.
  measure: postoperative complications
  time frame: within 7days and 30 days after surgery
  description: defined using comprehensive complication index
  measure: postoperative recovery
  time frame: within 7days and 30 days after surgery
  description: assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0
  measure: hospitalization expenses
  time frame: upon hospital discharge, typically 1-2 weeks
  description: total expense during the hospital stay
  measure: length of hospital stay
  time frame: upon hospital discharge，typically 1-2 weeks
  description: days of in hospital stay
  arm group label: Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)
  arm group type: Experimental
  description: Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
  arm group label: Group B (immunonutrition and routine oral care, IN&RC)
  arm group type: Experimental
  description: Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. For oral health care, they will receive routine oral care which is routine toothbrushing twice daily.
  arm group label: Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)
  arm group type: Experimental
  description: Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
  arm group label: Group D (routine nutrition advice and routine oral care, RN&RC)
  arm group type: No Intervention
  description: Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive routine oral care which is routine toothbrushing twice daily.
  intervention type: Dietary Supplement
  intervention name: immunonutrition supplement of ORAL IMPACT™
  description: For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.
  arm group label: Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)
  arm group label: Group B (immunonutrition and routine oral care, IN&RC)
  intervention type: Other
  intervention name: oral chlorhexidine decontamination
  description: For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.
  arm group label: Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)
  arm group label: Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yuguang Huang, Dr
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Lu Che, Dr
  phone: 69152020
  email: tracymaobao@126.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Postoperative Complications
  mesh term: Chlorhexidine
  sharing ipd: No