<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/NCT04461743</url>
  </required_header>
  <id_info>
    <org_study_id>2020</org_study_id>
    <nct_id>NCT04461743</nct_id>
  </id_info>
  <brief_title>Microcirculation Evolution in Patients After Cardiac Surgery</brief_title>
  <official_title>Microcirculation Evolution in Patients After Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</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>
      We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients&#xD;
      after cardiac surgery and compared the evolutions of those parameters between patients with&#xD;
      tissue hypoperfusion and normal perfusion. Consecutive patients after cardiac surgery who&#xD;
      required mechanical ventilation and for whom sublingual microcirculation measurements were&#xD;
      possible enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients&#xD;
      after cardiac surgery and compared the evolutions of those parameters between patients with&#xD;
      tissue hypoperfusion and normal perfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Microcirculation</measure>
    <time_frame>Extubation</time_frame>
    <description>PPV and MFI</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Patients After Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Patients with normal lac</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with abnormal lac</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention, regular therapy</description>
    <arm_group_label>Patients with abnormal lac</arm_group_label>
    <arm_group_label>Patients with normal lac</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients after cardiac surgery who required mechanical ventilation and for whom&#xD;
        sublingual microcirculation measurements were possible.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients after cardiac surgery.&#xD;
&#xD;
          -  Patients whom sublingual microcirculation measurements were possible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moribund patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jingyuan Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southeast University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jingyuan Xu</last_name>
    <phone>8613851417209</phone>
    <email>xujingyuanmail@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Critical Care Medicine</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jingyuan Xu, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jingyuan,Xu</investigator_full_name>
    <investigator_title>Southeast University, China</investigator_title>
  </responsible_party>
  <keyword>microcirculation</keyword>
  <keyword>cardiac surgery</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04461743
org study id: 2020
nct id: NCT04461743
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients
      after cardiac surgery and compared the evolutions of those parameters between patients with
      tissue hypoperfusion and normal perfusion. Consecutive patients after cardiac surgery who
      required mechanical ventilation and for whom sublingual microcirculation measurements were
      possible enrolled.
We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients
      after cardiac surgery and compared the evolutions of those parameters between patients with
      tissue hypoperfusion and normal perfusion.
observational model: Cohort
time perspective: Prospective
measure: Microcirculation
time frame: Extubation
description: PPV and MFI
arm group label: Patients with normal lac
arm group label: Patients with abnormal lac
intervention type: Other
intervention name: No intervention
description: No intervention, regular therapy
arm group label: Patients with abnormal lac
arm group label: Patients with normal lac
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jingyuan Xu
role: Principal Investigator
affiliation: Southeast University
last name: Jingyuan Xu
phone: 8613851417209
email: xujingyuanmail@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Jingyuan,Xu
investigator title: Southeast University, China
sharing ipd: Undecided