<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/NCT04433468</url>
  </required_header>
  <id_info>
    <org_study_id>2020RIPC</org_study_id>
    <nct_id>NCT04433468</nct_id>
  </id_info>
  <brief_title>Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.</brief_title>
  <official_title>Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To observe the effect of RIPC on the function of vital organs after cardiac surgery, and to&#xD;
      explore its possible mechanism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of acute renal injury after operation</measure>
    <time_frame>within 7 days after operation</time_frame>
    <description>According to the (KDIGO) guidelines for improving the prognosis of renal disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence of postoperative delirium</measure>
    <time_frame>within 7 days after operation</time_frame>
    <description>CAM score greater than 22</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>RIPC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RIPC</intervention_name>
    <description>The tourniquet attached to the upper limb was inflated and blocked for 5 minutes, then deflated for 5 minutes to restore blood flow and induce ischemic preconditioning.</description>
    <arm_group_label>RIPC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with aortic valve, mitral valve, tricuspid valve, ascending aortic disease&#xD;
             and coronary atherosclerosis who were admitted to hospital for elective valve repair,&#xD;
             replacement, artificial vascular replacement or coronary artery bypass grafting.&#xD;
&#xD;
          -  age 18-80 years old.&#xD;
&#xD;
          -  No restriction on gender.&#xD;
&#xD;
          -  ASA grade II~III.&#xD;
&#xD;
          -  NYHAII~III level.&#xD;
&#xD;
          -  the patient or his family member has signed the informed consent form for the clinical&#xD;
             trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those who are disabled in the selected test.&#xD;
&#xD;
          -  less than 5 years of education.&#xD;
&#xD;
          -  The preoperative left ventricular ejection fraction ((LVEF)) was less than 40%.&#xD;
&#xD;
          -  Myocardial infarction occurred in nearly one month.&#xD;
&#xD;
          -  malignant tumor, hematological disease, severe liver and kidney dysfunction, recent&#xD;
             severe infection, etc.&#xD;
&#xD;
          -  History of nervous system, immune system and mental illness.&#xD;
&#xD;
          -  recent operation history of heart, brain, lung, liver, kidney and other important&#xD;
             organs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>180 Fenglin Road</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433468
org study id: 2020RIPC
nct id: NCT04433468
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To observe the effect of RIPC on the function of vital organs after cardiac surgery, and to
      explore its possible mechanism.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: The incidence of acute renal injury after operation
time frame: within 7 days after operation
description: According to the (KDIGO) guidelines for improving the prognosis of renal disease
measure: The incidence of postoperative delirium
time frame: within 7 days after operation
description: CAM score greater than 22
arm group label: RIPC
arm group type: Active Comparator
arm group label: Control
arm group type: No Intervention
intervention type: Device
intervention name: RIPC
description: The tourniquet attached to the upper limb was inflated and blocked for 5 minutes, then deflated for 5 minutes to restore blood flow and induce ischemic preconditioning.
arm group label: RIPC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No