<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/NCT03818126</url>
  </required_header>
  <id_info>
    <org_study_id>DELNIDO01</org_study_id>
    <nct_id>NCT03818126</nct_id>
  </id_info>
  <brief_title>The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement</brief_title>
  <official_title>The Del Nido Cardioplegia Versus the Cold Blood Cardioplegia in Adult Patients Undergoing Aortic Valve Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pawel Buszman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American Heart of Poland</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>
      A group of 150 patients undergoing aortic valve replacement procedure will be randomized&#xD;
      either into del Nido cardioprotection protocol (75 participants) or into the cold blood&#xD;
      cardioplegia protocol (75 participants).&#xD;
&#xD;
      The intraoperative and perioperative outcomes of using each solution will be presented and&#xD;
      compared (see the endpoints).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The del Nido cardioplegia was developed by Pedro del Nido and his team at the University of&#xD;
      Pittsburgh in 1990s. It was primarily designed for children and it has been used in pediatric&#xD;
      cardiac surgery in Boston's Children Hospital since 1994.&#xD;
&#xD;
      There are few studies regarding the del Nido cardioplegia. A prospective, randomized trial&#xD;
      was designed to determine the efficiency of the del Nido cardioplegia when compared to&#xD;
      multidose cold blood cardioplegia in cardiac procedures with short and moderate cross-clamp&#xD;
      times.&#xD;
&#xD;
      For the analysis of two cardioprotection protocols, it is essential to compare groups equal&#xD;
      in terms of the surgery and perioperative care, with the same surgical risk and cross-clamp&#xD;
      time. The research required elimination of all the unnecessary variables.&#xD;
&#xD;
      The patients undergoing aortic valve replacement procedure were selected as a study&#xD;
      population. A group of 150 patients will be randomized either into del Nido cardioprotection&#xD;
      protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).&#xD;
&#xD;
      The intraoperative and perioperative outcomes of using each solution will be presented and&#xD;
      compared (see the endpoints).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electrical cardiac activity during cross-clamp</measure>
    <time_frame>intraoperative</time_frame>
    <description>Electrical activity observed during the cardiac arrest (cross-clamp)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ventricular fibrillation during reperfusion</measure>
    <time_frame>intraoperative</time_frame>
    <description>Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hs-TnT (High sensitivity troponin T) - 24 hours</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>High sensitivity troponin T measured 24 hours postoperatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hs-TnT (High sensitivity troponin T) - 48 hours</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>High sensitivity troponin T measured 48 hours postoperatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CK-MB (Creatine kinase- MB isoenzyme) - 24 hours</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Creatine kinase (MB isoenzyme) measured 24 hours postoperatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CK-MB (Creatine kinase- MB isoenzyme) - 48 hours</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>Creatine kinase (MB isoenzyme) measured 48 hours postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ventricular fibrillation during the cardioplegia administration</measure>
    <time_frame>intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from the beginning of cardioplegia administration to cardiac arrest</measure>
    <time_frame>intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural use of the pacemaker</measure>
    <time_frame>intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative myocardial infarction</measure>
    <time_frame>intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall of ejection fraction (EF)</measure>
    <time_frame>48 hours</time_frame>
    <description>5% fall in the EF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inotrope administration</measure>
    <time_frame>intraoperative, 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of the intraaortic balloon pump</measure>
    <time_frame>intraoperative, 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative atrial fibrillation</measure>
    <time_frame>up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative arrhythmia (other than AF)</measure>
    <time_frame>up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative packed red blood cells transfusion</measure>
    <time_frame>up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative creatinine values</measure>
    <time_frame>up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney injury</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>The creatinine elevation &gt;25% or &gt;0.5mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVVHDF</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Use of continous veno-venous hemodiafiltration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>30 days postoperative</time_frame>
    <description>death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall mortality</measure>
    <time_frame>30 days postoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Aortic Valve Disease</condition>
  <condition>Ischemia-reperfusion Injury</condition>
  <arm_group>
    <arm_group_label>del Nido cardioplegia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>cold blood cardioplegia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>del Nido cardioplegia</intervention_name>
    <description>The del Nido components are: Plasma-Lyte A (1000ml), Mannitol 20% (16.3ml), MgSO4 50% (4ml) , NaHCO3 8.4% (13ml) , KCl 2mEq/mL (13ml), Lidocaine 1% (13ml). This solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 4:1 ratio (crystalloid:blood).&#xD;
The dosage is 20ml/kg. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius. Additional dose of the cardioplegia is given only if the cross-clamp time exceeds 90 minutes. Due to high volume given in a single delivery, 40 milligrams of furosemide are injected into cardiopulmonary circuit.</description>
    <arm_group_label>del Nido cardioplegia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cold blood cardioplegia</intervention_name>
    <description>The cold blood cardioplegia components are: Plasma-Lyte A (435ml), Mannitol 15% (20ml), NaHCO3 8.4% (20ml), KCl 2mEq/mL (25ml). The solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 1:4 ratio (crystalloid:blood).&#xD;
The initial dose is 15ml/kg and a dose of 5ml/kg is added every 20-30 minutes or whenever cardiac activity is observed. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius.</description>
    <arm_group_label>cold blood cardioplegia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  qualification for isolated aortic valve replacement&#xD;
&#xD;
          -  age&gt;18 years&#xD;
&#xD;
          -  given consent for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  reoperation&#xD;
&#xD;
          -  allergy to lidocaine&#xD;
&#xD;
          -  coronary artery disease requiring surgical or percutaneous intervention&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  ejection fraction&lt;30%&#xD;
&#xD;
          -  massive aortic calcification (&quot;porcelain aorta&quot;)&#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>Marek Cisowski, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biala, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1st Department of Cardiac Surgery</name>
      <address>
        <city>Bielsko-Biała</city>
        <zip>43-316</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>American Heart of Poland</investigator_affiliation>
    <investigator_full_name>Pawel Buszman</investigator_full_name>
    <investigator_title>Chief Executive Officer</investigator_title>
  </responsible_party>
  <keyword>del Nido</keyword>
  <keyword>cardioplegia</keyword>
  <keyword>aortic valve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Reperfusion Injury</mesh_term>
    <mesh_term>Aortic Valve Disease</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_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/NCT03818126
org study id: DELNIDO01
nct id: NCT03818126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A group of 150 patients undergoing aortic valve replacement procedure will be randomized
      either into del Nido cardioprotection protocol (75 participants) or into the cold blood
      cardioplegia protocol (75 participants).

      The intraoperative and perioperative outcomes of using each solution will be presented and
      compared (see the endpoints).
The del Nido cardioplegia was developed by Pedro del Nido and his team at the University of
      Pittsburgh in 1990s. It was primarily designed for children and it has been used in pediatric
      cardiac surgery in Boston's Children Hospital since 1994.

      There are few studies regarding the del Nido cardioplegia. A prospective, randomized trial
      was designed to determine the efficiency of the del Nido cardioplegia when compared to
      multidose cold blood cardioplegia in cardiac procedures with short and moderate cross-clamp
      times.

      For the analysis of two cardioprotection protocols, it is essential to compare groups equal
      in terms of the surgery and perioperative care, with the same surgical risk and cross-clamp
      time. The research required elimination of all the unnecessary variables.

      The patients undergoing aortic valve replacement procedure were selected as a study
      population. A group of 150 patients will be randomized either into del Nido cardioprotection
      protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).

      The intraoperative and perioperative outcomes of using each solution will be presented and
      compared (see the endpoints).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Electrical cardiac activity during cross-clamp
time frame: intraoperative
description: Electrical activity observed during the cardiac arrest (cross-clamp)
measure: Ventricular fibrillation during reperfusion
time frame: intraoperative
description: Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp
measure: hs-TnT (High sensitivity troponin T) - 24 hours
time frame: 24 hours postoperatively
description: High sensitivity troponin T measured 24 hours postoperatively
measure: hs-TnT (High sensitivity troponin T) - 48 hours
time frame: 48 hours postoperatively
description: High sensitivity troponin T measured 48 hours postoperatively
measure: CK-MB (Creatine kinase- MB isoenzyme) - 24 hours
time frame: 24 hours postoperatively
description: Creatine kinase (MB isoenzyme) measured 24 hours postoperatively
measure: CK-MB (Creatine kinase- MB isoenzyme) - 48 hours
time frame: 48 hours postoperatively
description: Creatine kinase (MB isoenzyme) measured 48 hours postoperatively
measure: Ventricular fibrillation during the cardioplegia administration
time frame: intraoperative
measure: Time from the beginning of cardioplegia administration to cardiac arrest
time frame: intraoperative
measure: Procedural use of the pacemaker
time frame: intraoperative
measure: Intraoperative myocardial infarction
time frame: intraoperative
measure: Fall of ejection fraction (EF)
time frame: 48 hours
description: 5% fall in the EF
measure: Inotrope administration
time frame: intraoperative, 48 hours
measure: Use of the intraaortic balloon pump
time frame: intraoperative, 48 hours
measure: Perioperative atrial fibrillation
time frame: up to 2 weeks
measure: Perioperative arrhythmia (other than AF)
time frame: up to 2 weeks
measure: Postoperative packed red blood cells transfusion
time frame: up to 2 weeks
measure: Perioperative creatinine values
time frame: up to 2 weeks
measure: Kidney injury
time frame: up to 2 weeks
description: The creatinine elevation >25% or >0.5mg/dl
measure: CVVHDF
time frame: up to 2 weeks
description: Use of continous veno-venous hemodiafiltration
measure: Cardiac death
time frame: 30 days postoperative
description: death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia).
measure: Overall mortality
time frame: 30 days postoperative
arm group label: del Nido cardioplegia
arm group type: Experimental
arm group label: cold blood cardioplegia
arm group type: Active Comparator
intervention type: Drug
intervention name: del Nido cardioplegia
description: The del Nido components are: Plasma-Lyte A (1000ml), Mannitol 20% (16.3ml), MgSO4 50% (4ml) , NaHCO3 8.4% (13ml) , KCl 2mEq/mL (13ml), Lidocaine 1% (13ml). This solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 4:1 ratio (crystalloid:blood).
The dosage is 20ml/kg. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius. Additional dose of the cardioplegia is given only if the cross-clamp time exceeds 90 minutes. Due to high volume given in a single delivery, 40 milligrams of furosemide are injected into cardiopulmonary circuit.
arm group label: del Nido cardioplegia
intervention type: Drug
intervention name: cold blood cardioplegia
description: The cold blood cardioplegia components are: Plasma-Lyte A (435ml), Mannitol 15% (20ml), NaHCO3 8.4% (20ml), KCl 2mEq/mL (25ml). The solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 1:4 ratio (crystalloid:blood).
The initial dose is 15ml/kg and a dose of 5ml/kg is added every 20-30 minutes or whenever cardiac activity is observed. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius.
arm group label: cold blood cardioplegia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marek Cisowski, MD,PhD
role: Principal Investigator
affiliation: 1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biala, Poland
facility: 
country: Poland
responsible party type: Sponsor-Investigator
investigator affiliation: American Heart of Poland
investigator full name: Pawel Buszman
investigator title: Chief Executive Officer
mesh term: Reperfusion Injury
mesh term: Aortic Valve Disease
mesh term: Ischemia
sharing ipd: No