<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/NCT03028389</url>
  </required_header>
  <id_info>
    <org_study_id>LRIP20170116</org_study_id>
    <nct_id>NCT03028389</nct_id>
  </id_info>
  <brief_title>Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery</brief_title>
  <acronym>LRIP-D</acronym>
  <official_title>Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery:a Randomised, Double-blind, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</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>
      To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the&#xD;
      incidence of delirium in elderly patients after non-cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We&#xD;
      hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the&#xD;
      incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes&#xD;
      included the incidence of delirium in the first 7 days after surgery using the Confusion&#xD;
      Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a&#xD;
      6-month period was evaluated as well.Secondary endpoints included length of stay in the&#xD;
      hospital after surgery (from day of surgery to hospital discharge), occurrence of&#xD;
      non-delirium postoperative complications, and all-cause 6-month mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2017</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the incidence of delirium</measure>
    <time_frame>in the first 7 days after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">611</enrollment>
  <condition>Elderly Patients</condition>
  <condition>Non-cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Limb RIPC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Convention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Elderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>limb remote ischemic preconditioning(LRIP)</intervention_name>
    <description>LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.</description>
    <arm_group_label>Limb RIPC</arm_group_label>
    <other_name>LRIP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elderly patients received elective non-cardiac surgery with general anesthesia&#xD;
&#xD;
          -  anticipated surgery time &gt; 2 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 65 years old&#xD;
&#xD;
          -  Acute coronary syndrome or myocardial infraction within 3 months&#xD;
&#xD;
          -  Chronic obstructive pulmonary emphysema&#xD;
&#xD;
          -  Serious hepatic dysfunction (Child-Pugh class C)&#xD;
&#xD;
          -  serious renal dysfunction (undergoing dialysis before surgery)&#xD;
&#xD;
          -  Ejection fraction less than 40%&#xD;
&#xD;
          -  Poor pulmonary function (PaO2 &lt;60mmHg)&#xD;
&#xD;
          -  Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis&#xD;
&#xD;
          -  Inability to communicate in the preoperative period (coma, profound dementia, or&#xD;
             language barrier)&#xD;
&#xD;
          -  Brain injury or neurosurgery&#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>Ke-Xuan Liu, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanfang Hospital, the Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jian Liu, MD</last_name>
    <phone>+86-15013228487</phone>
    <email>launfyy@126.com</email>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Kexuan Liu</investigator_full_name>
    <investigator_title>Department of Anesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, China</investigator_title>
  </responsible_party>
  <keyword>elderly patients</keyword>
  <keyword>non-cardiac surgery</keyword>
  <keyword>ischemic preconditioning</keyword>
  <keyword>delirium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <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/NCT03028389
org study id: LRIP20170116
nct id: NCT03028389
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the
      incidence of delirium in elderly patients after non-cardiac surgery.
Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We
      hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the
      incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes
      included the incidence of delirium in the first 7 days after surgery using the Confusion
      Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a
      6-month period was evaluated as well.Secondary endpoints included length of stay in the
      hospital after surgery (from day of surgery to hospital discharge), occurrence of
      non-delirium postoperative complications, and all-cause 6-month mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: the incidence of delirium
time frame: in the first 7 days after surgery
arm group label: Limb RIPC
arm group type: Experimental
description: The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.
arm group label: Convention
arm group type: No Intervention
description: Elderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia
intervention type: Procedure
intervention name: limb remote ischemic preconditioning(LRIP)
description: LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
arm group label: Limb RIPC
other name: LRIP
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Ke-Xuan Liu, Ph.D
role: Principal Investigator
affiliation: Nanfang Hospital, the Southern Medical University
last name: Jian Liu, MD
phone: +86-15013228487
email: launfyy@126.com
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Kexuan Liu
investigator title: Department of Anesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, China
mesh term: Delirium
sharing ipd: No