<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/NCT03229980</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008715918</org_study_id>
    <nct_id>NCT03229980</nct_id>
  </id_info>
  <brief_title>Pediatric Myocardial Protection With Potassium Cardioplegia</brief_title>
  <official_title>Pediatric Myocardial Protection; Large Volume Potassium Cardioplegia Advantageous Over Small Volume Potassium Cardioplegia: Where do we Stand?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of&#xD;
      congenital heart disease encourage us to discuss problems that occur during this surgery&#xD;
      especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging&#xD;
      systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI)&#xD;
      as a result of cessation and re-initiation of coronary artery circulation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval of the local ethics committee of Assiut University and obtaining written&#xD;
      informed consent from parents or guardians of all patients, 60 patients with congenital heart&#xD;
      disease will be included. Patients will be randomly allocated into three groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">April 28, 2018</completion_date>
  <primary_completion_date type="Actual">April 3, 2018</primary_completion_date>
  <phase>Phase 2</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>Cardiac rhythm on return</measure>
    <time_frame>within the first 24 hours</time_frame>
    <description>Sinus rhythm or Ventricular Fibrillation:&#xD;
DC will be used or not and if used how much joules and how many times.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The inotropic score</measure>
    <time_frame>within one month</time_frame>
    <description>1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. (i.e. 1 point is assigned for each 10 ng/kg/min of epinephrine, norepinephrine, and phenylephrine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac dysrhythmias</measure>
    <time_frame>within the first week</time_frame>
    <description>Cardiac dysrhythmias during intensive care unit stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>within the first 24 hours</time_frame>
    <description>blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transthoracic echocardiography (TTE) changes</measure>
    <time_frame>within the first week</time_frame>
    <description>Changes in ejection fraction by TTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin I levels</measure>
    <time_frame>within the first 24 hours</time_frame>
    <description>We will obtain blood samples for troponin I levels (as a marker of myocardial ischemia) pre-CBP, 6, 12 and 24 hours after the surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Cardioplegia</condition>
  <arm_group>
    <arm_group_label>Group L</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg The content of cardioplegic solution will be (K+, 10mmol/L) lidocaine 50 mg/L, magnesium sulphate 1 gm/L,dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery. Cardioplegic infusion duration will be infused over 300s.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group S</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg The content of cardioplegic solution will be (K+, 30mmol/L) lidocaine 150 mg/L, magnesium sulphate 3 gm/L, dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cold blood cardioplegia (large volume)</intervention_name>
    <description>Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg</description>
    <arm_group_label>Group L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cold blood cardioplegia (small volume)</intervention_name>
    <description>Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg</description>
    <arm_group_label>Group S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp&#xD;
             time&gt;45 minutes.&#xD;
&#xD;
          -  Hemodynamic stability.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous cardiac surgery.&#xD;
&#xD;
          -  Urgent or emergent cases.&#xD;
&#xD;
          -  Any known allergies to components of either cardioplegia solutions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sayed k Abd-Elshafy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate profossor of anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>May 9, 2018</last_update_submitted>
  <last_update_submitted_qc>May 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sayed Kaoud Abd-Elshafy</investigator_full_name>
    <investigator_title>Associate Profossor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>myocardial protection</keyword>
  <keyword>potassium cardioplegia</keyword>
  <keyword>tropinin</keyword>
  <keyword>Custodiol</keyword>
  <!-- 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/NCT03229980
org study id: IRB00008715918
nct id: NCT03229980
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of
      congenital heart disease encourage us to discuss problems that occur during this surgery
      especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging
      systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI)
      as a result of cessation and re-initiation of coronary artery circulation
After approval of the local ethics committee of Assiut University and obtaining written
      informed consent from parents or guardians of all patients, 60 patients with congenital heart
      disease will be included. Patients will be randomly allocated into three groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Cardiac rhythm on return
time frame: within the first 24 hours
description: Sinus rhythm or Ventricular Fibrillation:
DC will be used or not and if used how much joules and how many times.
measure: The inotropic score
time frame: within one month
description: 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. (i.e. 1 point is assigned for each 10 ng/kg/min of epinephrine, norepinephrine, and phenylephrine.
measure: Cardiac dysrhythmias
time frame: within the first week
description: Cardiac dysrhythmias during intensive care unit stay
measure: blood pressure
time frame: within the first 24 hours
description: blood pressure
measure: transthoracic echocardiography (TTE) changes
time frame: within the first week
description: Changes in ejection fraction by TTE
measure: Troponin I levels
time frame: within the first 24 hours
description: We will obtain blood samples for troponin I levels (as a marker of myocardial ischemia) pre-CBP, 6, 12 and 24 hours after the surgery.
arm group label: Group L
arm group type: Active Comparator
description: Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg The content of cardioplegic solution will be (K+, 10mmol/L) lidocaine 50 mg/L, magnesium sulphate 1 gm/L,dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery. Cardioplegic infusion duration will be infused over 300s.
arm group label: Group S
arm group type: Active Comparator
description: Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg The content of cardioplegic solution will be (K+, 30mmol/L) lidocaine 150 mg/L, magnesium sulphate 3 gm/L, dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery.
intervention type: Drug
intervention name: Cold blood cardioplegia (large volume)
description: Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg
arm group label: Group L
intervention type: Drug
intervention name: Cold blood cardioplegia (small volume)
description: Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg
arm group label: Group S
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
last name: Sayed k Abd-Elshafy, MD
role: Principal Investigator
affiliation: Associate profossor of anesthesiology
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sayed Kaoud Abd-Elshafy
investigator title: Associate Profossor of Anesthesiology