<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/NCT02248415</url>
  </required_header>
  <id_info>
    <org_study_id>NL40355</org_study_id>
    <nct_id>NCT02248415</nct_id>
  </id_info>
  <brief_title>Administration of Warm Blood Cardioplegia With or Without Roller Pump</brief_title>
  <official_title>Administration of Warm Blood Cardioplegia With or Without Roller Pump; a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Antonius Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Antonius Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the effect of warm blood cardioplegia administration with&#xD;
      and without roller pump on perioperative myocardial injury, reflected by postoperative&#xD;
      biomarker release, in patients undergoing coronary artery bypass grafting (CABG) with a&#xD;
      minimal extracorporeal circuit (MECC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients Sixty-eight patients undergoing elective coronary bypass surgery with a MECC system&#xD;
      were consecutively enrolled and randomized into a no pump group (blood cardioplegia&#xD;
      administration without roller pump) or pump group (blood cardioplegia administration with&#xD;
      roller pump). Exclusion criteria were: previous cardiac surgery, scheduled surgery with less&#xD;
      than 3 distal anastomoses, left ventricular ejection fraction &lt;45%, chronic renal failure&#xD;
      (defined by preoperative creatinine &gt;177 µmol/L) and aortic insufficiency ≥ grade 1. The&#xD;
      medical ethics committee of the St. Antonius Hospital approved this study and written&#xD;
      informed consent was obtained for each patient prior to the surgical procedure.&#xD;
&#xD;
      Administration of blood cardioplegia In all patients warm blood cardioplegia was administered&#xD;
      via the aortic root immediately after aortic cross-clamping. Warm blood cardioplegia&#xD;
      consisted of oxygenated blood with added Potassium Chloride/Magnesium Sulphate (KCl/Mg SO4;&#xD;
      Pharmacy Catharina Hospital, Eindhoven, The Netherlands: K+ 1.7 mmol/mL, Cl- 1.7 mmol/mL,&#xD;
      Mg2+ 0.17 mmol/mL en SO4- 0.17 mmol/mL). An infusion pump was used for the addition of KCl/Mg&#xD;
      SO4. Dosage was based on a blood cardioplegia flow of 200 mL/min and adjusted according to&#xD;
      the following protocol: the initial dose of KCl/MgSO4 was 5.7 mmol/min (= 6.7 mL), the second&#xD;
      dose was 3.4 mmol/min (= 4 mL) and subsequent doses were 2.6 mmol/min (= 3 mL). Each dose was&#xD;
      given over a period of 2 minutes. Every 15 minutes the administration of blood cardioplegia&#xD;
      was repeated. In case of recurring ECG activity, blood cardioplegia was given with aberrant&#xD;
      intervals.&#xD;
&#xD;
      In the no pump group blood cardioplegia was delivered using the arterial line pressure,&#xD;
      created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood&#xD;
      cardioplegia flow depended on the difference between arterial line pressure and aortic root&#xD;
      pressure. In the pump group blood cardioplegia was delivered using a roller pump. The blood&#xD;
      cardioplegia flow was given at 200 mL/min.&#xD;
&#xD;
      Blood sample collection and analyses Blood was collected in EDTA tubes (6 mL) at baseline&#xD;
      after induction of anaesthesia (T0), after arrival at the ICU (T1), 4 hours in ICU (T2) and&#xD;
      at the first postoperative day (T3). Blood samples were fractionated by centrifuging&#xD;
      1500-2000 x g for 15 min. Plasma was collected and stored at -80°C until analysis. The&#xD;
      following biomarkers were analysed: Troponin T high sensitive (TnT-hs), Heart-type Fatty Acid&#xD;
      Binding Protein (H-FABP), N-terminal brain natriuretic peptide (NT-pro-BNP) and C-reactive&#xD;
      protein (CRP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Troponin T high sensitive (TnT-hs) (ng/L)</measure>
    <time_frame>Change from baseline to the first postoperative day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)</measure>
    <time_frame>Change from baseline to the first postoperative day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)</measure>
    <time_frame>Change from baseline to the first postoperative day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reactive protein (CRP) (μg/mL)</measure>
    <time_frame>Change from baseline to the first postoperative day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood cardioplegia flow during blood cardioplegia delivery (mL/min)</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial line pressure during blood cardioplegia delivery (mmHg)</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aortic root pressure during blood cardioplegia delivery (mmHg)</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative myocardial infarction</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inotropic support (hours)</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIA/CVA</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pneumonia</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal failure</measure>
    <time_frame>30-days</time_frame>
    <description>Creatine&gt;177 μmol/l/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-thoracotomy</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay (hours)</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay (days)</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>No pump group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood cardioplegia administration without roller pump</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pump group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood cardioplegia administration with roller pump</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No pump</intervention_name>
    <description>In the no pump group blood cardioplegia was delivered using the arterial line pressure, created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood cardioplegia flow depended on the difference between arterial line pressure and aortic root pressure.</description>
    <arm_group_label>No pump group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pump</intervention_name>
    <description>In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.</description>
    <arm_group_label>Pump group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample collection: after induction of anaesthesia (T0)</intervention_name>
    <description>The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.</description>
    <arm_group_label>No pump group</arm_group_label>
    <arm_group_label>Pump group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample collection: after arrival at the ICU (T1)</intervention_name>
    <description>The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.</description>
    <arm_group_label>No pump group</arm_group_label>
    <arm_group_label>Pump group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample collection: 4 hours in ICU (T2)</intervention_name>
    <description>The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.</description>
    <arm_group_label>No pump group</arm_group_label>
    <arm_group_label>Pump group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample collection: the first postoperative day (T3)</intervention_name>
    <description>The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.</description>
    <arm_group_label>No pump group</arm_group_label>
    <arm_group_label>Pump group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective coronary artery bypass grafting&#xD;
&#xD;
          -  Scheduled surgery with less than 3 distal anastomoses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous cardiac surgery&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;45%&#xD;
&#xD;
          -  Chronic renal failure (defined by preoperative creatinine &gt;177 µmol/L)&#xD;
&#xD;
          -  Aortic insufficiency ≥ grade 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mizja Faber, Faber</last_name>
    <role>Principal Investigator</role>
    <affiliation>mizjafaber@heartbeat5.nl</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Antonius Hospital</investigator_affiliation>
    <investigator_full_name>Mizja M. Faber</investigator_full_name>
    <investigator_title>MSc</investigator_title>
  </responsible_party>
  <keyword>Cardioplegic Solutions</keyword>
  <keyword>Myocardial Ischemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT02248415
org study id: NL40355
nct id: NCT02248415
lead sponsor: 
has dmc: Yes
The aim of this study is to compare the effect of warm blood cardioplegia administration with
      and without roller pump on perioperative myocardial injury, reflected by postoperative
      biomarker release, in patients undergoing coronary artery bypass grafting (CABG) with a
      minimal extracorporeal circuit (MECC).
Patients Sixty-eight patients undergoing elective coronary bypass surgery with a MECC system
      were consecutively enrolled and randomized into a no pump group (blood cardioplegia
      administration without roller pump) or pump group (blood cardioplegia administration with
      roller pump). Exclusion criteria were: previous cardiac surgery, scheduled surgery with less
      than 3 distal anastomoses, left ventricular ejection fraction <45%, chronic renal failure
      (defined by preoperative creatinine >177 µmol/L) and aortic insufficiency ≥ grade 1. The
      medical ethics committee of the St. Antonius Hospital approved this study and written
      informed consent was obtained for each patient prior to the surgical procedure.

      Administration of blood cardioplegia In all patients warm blood cardioplegia was administered
      via the aortic root immediately after aortic cross-clamping. Warm blood cardioplegia
      consisted of oxygenated blood with added Potassium Chloride/Magnesium Sulphate (KCl/Mg SO4;
      Pharmacy Catharina Hospital, Eindhoven, The Netherlands: K+ 1.7 mmol/mL, Cl- 1.7 mmol/mL,
      Mg2+ 0.17 mmol/mL en SO4- 0.17 mmol/mL). An infusion pump was used for the addition of KCl/Mg
      SO4. Dosage was based on a blood cardioplegia flow of 200 mL/min and adjusted according to
      the following protocol: the initial dose of KCl/MgSO4 was 5.7 mmol/min (= 6.7 mL), the second
      dose was 3.4 mmol/min (= 4 mL) and subsequent doses were 2.6 mmol/min (= 3 mL). Each dose was
      given over a period of 2 minutes. Every 15 minutes the administration of blood cardioplegia
      was repeated. In case of recurring ECG activity, blood cardioplegia was given with aberrant
      intervals.

      In the no pump group blood cardioplegia was delivered using the arterial line pressure,
      created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood
      cardioplegia flow depended on the difference between arterial line pressure and aortic root
      pressure. In the pump group blood cardioplegia was delivered using a roller pump. The blood
      cardioplegia flow was given at 200 mL/min.

      Blood sample collection and analyses Blood was collected in EDTA tubes (6 mL) at baseline
      after induction of anaesthesia (T0), after arrival at the ICU (T1), 4 hours in ICU (T2) and
      at the first postoperative day (T3). Blood samples were fractionated by centrifuging
      1500-2000 x g for 15 min. Plasma was collected and stored at -80°C until analysis. The
      following biomarkers were analysed: Troponin T high sensitive (TnT-hs), Heart-type Fatty Acid
      Binding Protein (H-FABP), N-terminal brain natriuretic peptide (NT-pro-BNP) and C-reactive
      protein (CRP).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Troponin T high sensitive (TnT-hs) (ng/L)
time frame: Change from baseline to the first postoperative day
measure: Heart-type Fatty Acid Binding Protein (hFABP) (ng/mL)
time frame: Change from baseline to the first postoperative day
measure: N-terminal brain natriuretic peptide (NT-pro-BNP) (ng/mL)
time frame: Change from baseline to the first postoperative day
measure: C-reactive protein (CRP) (μg/mL)
time frame: Change from baseline to the first postoperative day
measure: Blood cardioplegia flow during blood cardioplegia delivery (mL/min)
time frame: Intraoperative
measure: Arterial line pressure during blood cardioplegia delivery (mmHg)
time frame: Intraoperative
measure: Blood cardioplegia line pressure during blood cardioplegia delivery (mmHg)
time frame: Intraoperative
measure: Aortic root pressure during blood cardioplegia delivery (mmHg)
time frame: Intraoperative
measure: Post-operative myocardial infarction
time frame: 30-days
measure: Inotropic support (hours)
time frame: 30-days
measure: TIA/CVA
time frame: 30-days
measure: Pneumonia
time frame: 30-days
measure: Renal failure
time frame: 30-days
description: Creatine>177 μmol/l/l
measure: Re-thoracotomy
time frame: 30-days
measure: Atrial fibrillation
time frame: 30-days
measure: Length of ICU stay (hours)
time frame: 30-days
measure: Length of hospital stay (days)
time frame: 30-days
arm group label: No pump group
arm group type: Experimental
description: Blood cardioplegia administration without roller pump
arm group label: Pump group
arm group type: Other
description: Blood cardioplegia administration with roller pump
intervention type: Other
intervention name: No pump
description: In the no pump group blood cardioplegia was delivered using the arterial line pressure, created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood cardioplegia flow depended on the difference between arterial line pressure and aortic root pressure.
arm group label: No pump group
intervention type: Other
intervention name: Pump
description: In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.
arm group label: Pump group
intervention type: Other
intervention name: Blood sample collection: after induction of anaesthesia (T0)
description: The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
arm group label: No pump group
arm group label: Pump group
intervention type: Other
intervention name: Blood sample collection: after arrival at the ICU (T1)
description: The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
arm group label: No pump group
arm group label: Pump group
intervention type: Other
intervention name: Blood sample collection: 4 hours in ICU (T2)
description: The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
arm group label: No pump group
arm group label: Pump group
intervention type: Other
intervention name: Blood sample collection: the first postoperative day (T3)
description: The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
arm group label: No pump group
arm group label: Pump group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mizja Faber, Faber
role: Principal Investigator
affiliation: mizjafaber@heartbeat5.nl
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: St. Antonius Hospital
investigator full name: Mizja M. Faber
investigator title: MSc
mesh term: Coronary Disease
mesh term: Anesthetics