<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/NCT04505059</url>
  </required_header>
  <id_info>
    <org_study_id>Precision-Delirium-Cognitive</org_study_id>
    <nct_id>NCT04505059</nct_id>
  </id_info>
  <brief_title>Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Patients Undergoing Cardiac Surgery</brief_title>
  <official_title>Effect of Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Adult Patients Undergoing Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China National Center for Cardiovascular Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tianjin Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China National Center for Cardiovascular Diseases</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective, multi-center, double-blind, randomized clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective randomized multi-center trial involving about 502 subjects will be enrolled in 3&#xD;
      centers. Patients will be randomized to two groups in equal proportion. Investigators set a&#xD;
      hypothesis that precision cardiac anesthesia, which involves the modification of several&#xD;
      crucial anesthetic modalities, would reduces the incidence of postoperative cognitive&#xD;
      function and delirium in patients undergoing cardiac surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Anticipated">January 18, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 18, 2022</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of postoperative delirium</measure>
    <time_frame>Postoperative day 1 to 5</time_frame>
    <description>Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative cognitive function</measure>
    <time_frame>In hospital,up to 10 days, at 1,6 and 12 months after surgery</time_frame>
    <description>Assessed by MoCA (score range from 0 to 30, higher scores mean a better outcome) or MMSE (score range from 0 to 30, higher scores mean a better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation time</measure>
    <time_frame>up to 1 month after surgery</time_frame>
    <description>Mechanical ventilation time after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>up to 2 months after surgery</time_frame>
    <description>Length of hospital and ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost</measure>
    <time_frame>up to 2 months after surgery</time_frame>
    <description>health care costs of hospital and ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PONV</measure>
    <time_frame>Postoperative day 1 to 5</time_frame>
    <description>To quantify postoperative nausea and vomiting the following score was used:&#xD;
0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Postoperative day 1 to 5, at 1,6 and 12 months after surgery</time_frame>
    <description>Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6, IL-8, IL-10</measure>
    <time_frame>Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery</time_frame>
    <description>Inflammatory factor (IL-6, IL-8, IL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-α</measure>
    <time_frame>Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery</time_frame>
    <description>Inflammatory factor (TNF-α)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1</measure>
    <time_frame>Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery</time_frame>
    <description>Blood Biomarker (IGF-1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP</measure>
    <time_frame>Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery</time_frame>
    <description>Blood Biomarker (CRP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>S-100β protein</measure>
    <time_frame>Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery</time_frame>
    <description>Blood Biomarker (S-100β protein)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genotype</measure>
    <time_frame>Before surgery</time_frame>
    <description>Number of participants with target gene</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of postoperative complications</measure>
    <time_frame>In hospital,up to 10 days, at 1,3 and 12 months after surgery</time_frame>
    <description>Postoperative main complications</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of mortality</measure>
    <time_frame>In hospital,up to 10 days, at 1,3 and 12 months after surgery</time_frame>
    <description>All-cause mortality</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient's life quality</measure>
    <time_frame>At 1,3 and 12 months after surgery</time_frame>
    <description>Quality of life was assessed by SF-36. A self-administered 36-item question- naire covering eight different domains: physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health. Raw points are transformed into a score from 0 to 100 for each dimension, with 100 reflecting the best possible health-related quality of life.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">502</enrollment>
  <condition>Delirium</condition>
  <condition>Condition</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Precision cardiac anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional cardiac anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Institutional standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Precision cardiac anesthesia</intervention_name>
    <description>Aperi-operative anesthetic management through target-controlled infusion to accurately control the patient blood concentration, with combination of bispectral index and neuromuscular monitoring to adjust the dosage of general anesthetics.</description>
    <arm_group_label>Precision cardiac anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional cardiac anesthesia</intervention_name>
    <description>The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience</description>
    <arm_group_label>Conventional cardiac anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged≥18 years;&#xD;
&#xD;
          2. ASA:I to III;&#xD;
&#xD;
          3. Hemodynamic stability, LVEF≥40%;&#xD;
&#xD;
          4. Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery,&#xD;
             surgical repair of ASD,VSD and atrial myxoma, and other types.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Declined to get involved;&#xD;
&#xD;
          2. Emergency cases, heart transplantation;&#xD;
&#xD;
          3. Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency&#xD;
             (requirement of renal replacement therapy);&#xD;
&#xD;
          4. Previous history of drug and alcohol abuse,allergy to general anesthetics;&#xD;
&#xD;
          5. Preoperative severe dementia, language barrier and mental illness&#xD;
&#xD;
          6. Preoperative schizophrenia, epilepsy, stroke and Parkinson's disease&#xD;
&#xD;
          7. Previous history of craniocerebral injury or neurosurgery;&#xD;
&#xD;
          8. Any other conditions that are considered unsuitable for study participation.&#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_official>
    <last_name>Yuefu Wang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&amp;PUMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jiange Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Chest Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Haitao Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Hospital of Hebei Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuefu Wang, MD</last_name>
    <phone>+(86)010-88396509</phone>
    <email>wangyuefu@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yuchen Gao, MD</last_name>
    <phone>+(86)010-88392469</phone>
    <email>gaoyuchen_pumc@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Second Hospital of HeBei Medical University</name>
      <address>
        <city>Shijia Zhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haitao Liu, MD</last_name>
      <phone>+(86)15130119853</phone>
      <email>mzlht@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&amp;PUMC</name>
      <address>
        <city>Beijing</city>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuefu Wang, MD</last_name>
      <phone>+(86) 010-88396509</phone>
      <email>wangyuefu@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Chunrong Wang, MD</last_name>
      <phone>+(86) 010-88392469</phone>
      <email>Emancipation258@outlook.com</email>
    </contact_backup>
    <investigator>
      <last_name>Yuefu Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Chest Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300222</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiange Han, MD</last_name>
      <phone>+(86)022-88185152</phone>
      <email>hanjiange@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China National Center for Cardiovascular Diseases</investigator_affiliation>
    <investigator_full_name>Yuefu Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Postoperative cognitive function</keyword>
  <keyword>Delirium</keyword>
  <keyword>Cardiac Surgical Procedures</keyword>
  <keyword>Precision cardiac anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT04505059
org study id: Precision-Delirium-Cognitive
nct id: NCT04505059
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multi-center, double-blind, randomized clinical trials.
Prospective randomized multi-center trial involving about 502 subjects will be enrolled in 3
      centers. Patients will be randomized to two groups in equal proportion. Investigators set a
      hypothesis that precision cardiac anesthesia, which involves the modification of several
      crucial anesthetic modalities, would reduces the incidence of postoperative cognitive
      function and delirium in patients undergoing cardiac surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Rate of postoperative delirium
time frame: Postoperative day 1 to 5
description: Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period
measure: Postoperative cognitive function
time frame: In hospital,up to 10 days, at 1,6 and 12 months after surgery
description: Assessed by MoCA (score range from 0 to 30, higher scores mean a better outcome) or MMSE (score range from 0 to 30, higher scores mean a better outcome)
measure: Ventilation time
time frame: up to 1 month after surgery
description: Mechanical ventilation time after surgery
measure: Length of stay
time frame: up to 2 months after surgery
description: Length of hospital and ICU stay
measure: Cost
time frame: up to 2 months after surgery
description: health care costs of hospital and ICU
measure: PONV
time frame: Postoperative day 1 to 5
description: To quantify postoperative nausea and vomiting the following score was used:
0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting.
measure: Postoperative pain
time frame: Postoperative day 1 to 5, at 1,6 and 12 months after surgery
description: Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)
measure: IL-6, IL-8, IL-10
time frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery
description: Inflammatory factor (IL-6, IL-8, IL-10)
measure: TNF-α
time frame: Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
description: Inflammatory factor (TNF-α)
measure: IGF-1
time frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
description: Blood Biomarker (IGF-1)
measure: CRP
time frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
description: Blood Biomarker (CRP)
measure: S-100β protein
time frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
description: Blood Biomarker (S-100β protein)
measure: Genotype
time frame: Before surgery
description: Number of participants with target gene
measure: Rate of postoperative complications
time frame: In hospital,up to 10 days, at 1,3 and 12 months after surgery
description: Postoperative main complications
measure: Rate of mortality
time frame: In hospital,up to 10 days, at 1,3 and 12 months after surgery
description: All-cause mortality
measure: Patient's life quality
time frame: At 1,3 and 12 months after surgery
description: Quality of life was assessed by SF-36. A self-administered 36-item question- naire covering eight different domains: physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health. Raw points are transformed into a score from 0 to 100 for each dimension, with 100 reflecting the best possible health-related quality of life.
arm group label: Precision cardiac anesthesia
arm group type: Experimental
description: Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation
arm group label: Conventional cardiac anesthesia
arm group type: Active Comparator
description: Institutional standard of care.
intervention type: Procedure
intervention name: Precision cardiac anesthesia
description: Aperi-operative anesthetic management through target-controlled infusion to accurately control the patient blood concentration, with combination of bispectral index and neuromuscular monitoring to adjust the dosage of general anesthetics.
arm group label: Precision cardiac anesthesia
intervention type: Procedure
intervention name: Conventional cardiac anesthesia
description: The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience
arm group label: Conventional cardiac anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuefu Wang, MD
role: Study Director
affiliation: Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
last name: Jiange Han, MD
role: Principal Investigator
affiliation: Tianjin Chest Hospital
last name: Haitao Liu, MD
role: Principal Investigator
affiliation: The Second Hospital of Hebei Medical University
last name: Yuefu Wang, MD
phone: +(86)010-88396509
email: wangyuefu@hotmail.com
last name: Yuchen Gao, MD
phone: +(86)010-88392469
email: gaoyuchen_pumc@hotmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China National Center for Cardiovascular Diseases
investigator full name: Yuefu Wang
investigator title: Professor
mesh term: Delirium
mesh term: Anesthetics
sharing ipd: No