<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/NCT01713166</url>
  </required_header>
  <id_info>
    <org_study_id>YSJeon_crystalloid vs colloid</org_study_id>
    <nct_id>NCT01713166</nct_id>
  </id_info>
  <brief_title>Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of crystalloid and colloid, which are&#xD;
      used for pump priming solution, on the microcirculatory alterations during cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery slope</measure>
    <time_frame>until 2 days after surgery</time_frame>
    <description>Recovery slope is a marker of microcirculation. The tissue oxygen saturation (StO2) using InspectraTM StO2 (Hutchinson Technology Inc.,USA) will be recorded continuously. The InspectraTM StO2 probe will be placed on the skin of the thenar eminence and the blood pressure cuff will be wrapped around the arm. After performing vascular occlusion test, the recovery slope will be calculated by the software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>syndecan-1</measure>
    <time_frame>until 2 days after surgery</time_frame>
    <description>marker of glycocalyx degradation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>lactate</measure>
    <time_frame>until 2 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>StO2 (tissue oxygen saturation)</measure>
    <time_frame>until 2 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine</measure>
    <time_frame>until 2 days after surgery</time_frame>
    <description>Interleukin (IL)-1b, IL-6, IL-8, IL-10, TNF-a</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Plasmalyte solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Plasmalyte solution infusion to meet the fluid requirements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hextend</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6% Hetastarch administeration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>plasmalyte solution</intervention_name>
    <description>plasmalyte solution</description>
    <arm_group_label>Plasmalyte solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hextend</intervention_name>
    <description>Hetastarch administration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.</description>
    <arm_group_label>Hextend</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Off-pump Coronary Artery Bypass Surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  Postoperative use of steroid&#xD;
&#xD;
          -  Liver cirrhosis, Child-Pugh C&#xD;
&#xD;
          -  Renal disease on hemodialysis&#xD;
&#xD;
          -  Patients who cannot receive vascular occlusion test (severe peripheral vascular&#xD;
             disease, arteriovenous fistula, burn)&#xD;
&#xD;
          -  EF &lt; 40% on the preoperative echocardiography&#xD;
&#xD;
          -  Preoperative use of vasopressors or inotropic agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>June 15, 2016</last_update_submitted>
  <last_update_submitted_qc>June 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yunseok Jeon</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plasma-lyte 148</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01713166
org study id: YSJeon_crystalloid vs colloid
nct id: NCT01713166
lead sponsor: 
has dmc: No
The purpose of this study is to compare the effects of crystalloid and colloid, which are
      used for pump priming solution, on the microcirculatory alterations during cardiac surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Recovery slope
time frame: until 2 days after surgery
description: Recovery slope is a marker of microcirculation. The tissue oxygen saturation (StO2) using InspectraTM StO2 (Hutchinson Technology Inc.,USA) will be recorded continuously. The InspectraTM StO2 probe will be placed on the skin of the thenar eminence and the blood pressure cuff will be wrapped around the arm. After performing vascular occlusion test, the recovery slope will be calculated by the software.
measure: syndecan-1
time frame: until 2 days after surgery
description: marker of glycocalyx degradation
measure: lactate
time frame: until 2 days after surgery
measure: StO2 (tissue oxygen saturation)
time frame: until 2 days after surgery
measure: Cytokine
time frame: until 2 days after surgery
description: Interleukin (IL)-1b, IL-6, IL-8, IL-10, TNF-a
arm group label: Plasmalyte solution
arm group type: Active Comparator
description: Plasmalyte solution infusion to meet the fluid requirements.
arm group label: Hextend
arm group type: Experimental
description: 6% Hetastarch administeration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.
intervention type: Drug
intervention name: plasmalyte solution
description: plasmalyte solution
arm group label: Plasmalyte solution
intervention type: Drug
intervention name: Hextend
description: Hetastarch administration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.
arm group label: Hextend
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yunseok Jeon
investigator title: Associate Professor
mesh term: Plasma-lyte 148