<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/NCT03302286</url>
  </required_header>
  <id_info>
    <org_study_id>2017/422</org_study_id>
    <nct_id>NCT03302286</nct_id>
  </id_info>
  <brief_title>Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery</brief_title>
  <acronym>Prime</acronym>
  <official_title>Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</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>
      About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used&#xD;
      almost exclusively in all heart operations. This machine fills the role of heart and lungs&#xD;
      during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in&#xD;
      hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and&#xD;
      total protein content. This hemodilution is an unavoidable consequence of the use of a&#xD;
      heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and&#xD;
      electrolytes is affected by the prime solution and can be maintained within normal limits.&#xD;
      There are no clear recommendation regarding prime components and numerous prime solutions are&#xD;
      in use worldwide.&#xD;
&#xD;
      The aim of this study is to investigate whether the use of mannitol in heart-lung machine&#xD;
      prime has an effect on electrolytes levels and osmolality when compared with patients who&#xD;
      receive no Mannitol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 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>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>osmolality</measure>
    <time_frame>Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.</time_frame>
    <description>This study uses blood samples that are taken at predefined timepoints.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>urine outcome</measure>
    <time_frame>Measurements will be taken during first 24 hours following cardiac surgery</time_frame>
    <description>Production of urine will be studed following cardiac operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Mannitol Prime</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will undergo cardiac surgery with heart-lung machine with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NonMannitol Prime</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive a priming solution of Ringer´s acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Heart-lung machine primining solution which includes Mannitol</intervention_name>
    <description>This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium.</description>
    <arm_group_label>Mannitol Prime</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Heart-lung machine primining solution which does not include Mannitol</intervention_name>
    <description>This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.</description>
    <arm_group_label>NonMannitol Prime</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients of both sexes who will undergo elective isolated coronary artery bypass&#xD;
             grafting at the Department of Cardiothoracic Surgery, Skåne University Hospital, Lund&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart failure with left ventricular ejection fraction below 50%&#xD;
&#xD;
          -  small size (defined as bodyweight less than 50 kg)&#xD;
&#xD;
          -  anaemia with haematocrit less than 24%&#xD;
&#xD;
          -  patients with previous cardiac surgery&#xD;
&#xD;
          -  patients who receive other fluids or more than 1000 ml additional Ringers's Acetate&#xD;
             during cardiopulmonary bypass&#xD;
&#xD;
          -  patients with peroperative complications including massive peroperative fluid&#xD;
             transfusions&#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>Snejana Hyllen, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Skane</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thorax</name>
      <address>
        <city>Lund</city>
        <state>Skane</state>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Skane</investigator_affiliation>
    <investigator_full_name>Snejana Hyllén</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Heart-Lung Machine</keyword>
  <keyword>Cardiopulmonary Bypass</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mannitol</mesh_term>
    <mesh_term>Pharmaceutical Solutions</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/NCT03302286
org study id: 2017/422
nct id: NCT03302286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used
      almost exclusively in all heart operations. This machine fills the role of heart and lungs
      during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in
      hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and
      total protein content. This hemodilution is an unavoidable consequence of the use of a
      heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and
      electrolytes is affected by the prime solution and can be maintained within normal limits.
      There are no clear recommendation regarding prime components and numerous prime solutions are
      in use worldwide.

      The aim of this study is to investigate whether the use of mannitol in heart-lung machine
      prime has an effect on electrolytes levels and osmolality when compared with patients who
      receive no Mannitol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: osmolality
time frame: Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.
description: This study uses blood samples that are taken at predefined timepoints.
measure: urine outcome
time frame: Measurements will be taken during first 24 hours following cardiac surgery
description: Production of urine will be studed following cardiac operation
arm group label: Mannitol Prime
arm group type: Active Comparator
description: This group will undergo cardiac surgery with heart-lung machine with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium.
arm group label: NonMannitol Prime
arm group type: Active Comparator
description: This group will receive a priming solution of Ringer´s acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.
intervention type: Diagnostic Test
intervention name: Heart-lung machine primining solution which includes Mannitol
description: This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium.
arm group label: Mannitol Prime
intervention type: Diagnostic Test
intervention name: Heart-lung machine primining solution which does not include Mannitol
description: This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.
arm group label: NonMannitol Prime
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Snejana Hyllen, phd
role: Principal Investigator
affiliation: Region Skane
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Skane
investigator full name: Snejana Hyllén
investigator title: MD
mesh term: Mannitol
mesh term: Pharmaceutical Solutions
sharing ipd: No